Model Number L311 |
Device Problem
Adverse Event Without Identified Device or Use Problem (2993)
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Patient Problems
Hematoma (1884); Implant Pain (4561)
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Event Date 08/19/2022 |
Event Type
Injury
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Event Description
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It was reported that the patient with this pacemaker had painful pocket hematoma from the recent device implant.The physician performed a pocket evacuation to remove the hematoma.The device was repositioned to sub pectoral and placed pressure dressing on the wound.The device remains in service.No additional adverse patient effects were reported.
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Manufacturer Narrative
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If information is provided in the future, a supplemental report will be issued.
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Event Description
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It was reported that the patient with this pacemaker had painful pocket hematoma from the recent device implant.The physician performed a pocket evacuation to remove the hematoma.The device was repositioned to sub pectoral and placed pressure dressing on the wound.The device remains in service.No additional adverse patient effects were reported.Additional information was received indicating that this device was surgically explanted.No additional adverse patient effects reported.This event was previously reported.See mfr.Report # 2124215-2023-54325.
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Manufacturer Narrative
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If information is provided in the future, a supplemental report will be issued.This supplemental report was created to update the entry in d6b: explant date and h6: impact codes.This event was previously reported.See mfr.Report # 2124215-2023-54325.
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Event Description
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It was reported that the patient with this pacemaker had painful pocket hematoma from the recent device implant.The physician performed a pocket evacuation to remove the hematoma.The device was repositioned to sub pectoral and placed pressure dressing on the wound.The device remains in service.No additional adverse patient effects were reported.Additional information was received indicating that this device was surgically explanted.No additional adverse patient effects reported.
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Manufacturer Narrative
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If information is provided in the future, a supplemental report will be issued.This supplemental report was created to update the entry in d6b: explant date and h6: impact codes.This event was previously reported.See mfr.Report # 2124215-2023-54325.The returned device was thoroughly inspected and analyzed upon receipt at our post market quality assurance laboratory.Visual examination of the device header and case noted no anomalies.Dimensional analysis of the header was completed.Each port measured as expected.The device was then exposed to simulated heart load conditions, and the pacing, and sensing functions were tested.Impedance testing was completed, and all measurements were within normal limits.The device operated appropriately with no interruptions in therapy output at the returned programmed settings.A series of electrical tests was also performed, and again, normal device function was observed.Analysis did not identify any device characteristics that would have caused or contributed to the reported clinical observations.
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Search Alerts/Recalls
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