Model Number L311 |
Device Problems
Defective Device (2588); Adverse Event Without Identified Device or Use Problem (2993)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 12/16/2022 |
Event Type
Injury
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Event Description
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It was reported that an implantable pacemaker was explanted due to product performance issue.A new device was successfully implanted.No additional adverse patient effects were reported.
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Manufacturer Narrative
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This report contains additional information received related to the cause of the explant.Refer to field b5.
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Event Description
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It was reported that an implantable pacemaker was explanted due to product performance issue.A new device was successfully implanted.No additional adverse patient effects were reported.Subsequently, additional information was received indicating device was explanted due to therapy upgrade.
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Search Alerts/Recalls
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