Reversion to Back‐Up Mode (VOO) in a DDD Pacemaker Model

Turner, Mark; Zacharkiw, Linda; Marshall, Andrew J.

doi:10.1111/j.1540-8159.1998.tb00251.x

Cited by 4 publications

(2 citation statements)

References 3 publications

Supporting

Mentioning

Contrasting

Order By: Relevance

“…This report describes a significant discrepancy in malfunction rates as estimated by the manufacturer, compared to those observed by the implanting physician. A similar discrepancy was described by Turner et al 19 It is conceivable that the clustering of malfunctioning devices in a single center/area is the result of shipment of a dysfunctional “batch” to that center/area. In that case, finding one malfunctioning device should warrant prompt evaluation of all other units from the same “batch.” While local information is indispensable for local decision making, it cannot replace the worldwide perspective currently provided by manufacturers.…”

Section: Discussionsupporting

confidence: 69%

Managing Pacemaker Safety Alerts:

Gurevitz¹,

Granit²,

Bar‐Lev³

et al. 2003

Pacing Clinical Electrophis

View full text Add to dashboard Cite

This report describes the experience of a large pacemaker center during three successive replacement operations due to safety alerts involving three models from the same manufacturer. Between March 1993 and May 1999, 210 patients were implanted with three DDD pacemaker models (Sorin Biomedica, Saluggia, Italy) that were subsequently subject to safety alerts. Pacemaker records were reviewed for complications related to device malfunction, and those secondary to the replacement procedure. Pacemaker malfunction was observed in 16.4% of units despite much lower estimates from the company (range 1-4%). With the exception of one, all units were replaced. Malfunctions were discovered in 7 of 20 pacemakers following an urgent call for follow-up issued as a result of the alert. Twenty units implanted as substitutes for those replaced following the first alert turned out to be subject to the third alert. Significant clinical consequences of malfunction occurred in 5.3% of patients including a near fatal event in one case, while complications related to the replacement procedure occurred in 8.3% of patients, including one fatality. On the issuance of a safety alert, failure rates in a particular center may be higher than published by the manufacturer, and should prompt action by the center to weigh local incidence of device failure against complications of replacement procedures. When device failure mechanism is not entirely clear, particularly in cases of successive model failures, replacement devices from a different manufacturer should be considered.

show abstract

Section: Discussionsupporting

confidence: 69%

Managing Pacemaker Safety Alerts:

Gurevitz¹,

Granit²,

Bar‐Lev³

et al. 2003

Pacing Clinical Electrophis

View full text Add to dashboard Cite

show abstract

“…This type of intermittent mode reversion to VOO of a DDD pacing system was reported before in Sorin Physiocor 400 (Sorin Biomedica, Saluggia, Italy) series in four patients. 1 None of the patients who were found to have mode reversion gave any history to suggest that they had been exposed to electromagnetic interference. There are a few reports in the literature regarding mode reversion to VOO due to electro-magnetic interference (EMI) or noise detection.…”

Section: Discussionmentioning

confidence: 99%