Model Number ENO DR |
Device Problem
Pacing Intermittently (1443)
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Patient Problem
Complete Heart Block (2627)
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Event Date 11/20/2019 |
Event Type
malfunction
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Manufacturer Narrative
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The device model involved in this mdr report is not approved in the united states; however, it is similar to a device manufactured by sorin that was cleared or approved by fda for marketing in the united states.
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Event Description
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Reportedly during a pacemaker replacement procedure, it was not possible to pre-program the subject device in bipolar settings.Pacing outside the pocket was observed, however when placing the device in the pocket, the device stopped pacing.The subject device was removed from the pocket and pacing started again.Therefore, it was decided to implant another device.
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Event Description
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Reportedly during a pacemaker replacement procedure, due to the automatic implantation settings, it was not possible to pre-program the subject device in bipolar settings.Pacing outside the pocket was observed, however when placing the device in the pocket, the device stopped pacing.The subject device was removed from the pocket and pacing started again.Therefore, it was decided to implant another device.
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Manufacturer Narrative
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Please refer to the attached analysis report.
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Manufacturer Narrative
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B5 updated.Preliminary analysis on the returned device did not reveal any issue with the subject pacemaker.
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Event Description
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Reportedly during a pacemaker replacement procedure, due to the automatic implantation settings, it was not possible to pre-program the subject device in bipolar settings.Pacing outside the pocket was observed, however when placing the device in the pocket, the device stopped pacing.The subject device was removed from the pocket and pacing started again.Therefore, it was decided to implant another device.
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Search Alerts/Recalls
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