Model Number A219 |
Device Problems
Failure to Sense (1559); Low impedance (2285)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 03/11/2024 |
Event Type
Injury
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Event Description
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It was reported that at a recent follow-up appointment the impedance of the subcutaneous implantable cardioverter defibrillator (s-icd) system was less than 30 ohms and there was a lack of sensing in the primary vector.X-ray revealed that the electrode had pulled back, resulting in sense b being in close proximity to the pocket.The patient underwent complete system replacement.No additional adverse patient effects were reported.
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Event Description
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It was reported that at a recent follow-up appointment the impedance of the subcutaneous implantable cardioverter defibrillator (s-icd) system was less than 30 ohms and there was a lack of sensing in the primary vector.X-ray revealed that the electrode had pulled back, resulting in sense b being in close proximity to the pocket.The patient underwent complete system replacement.No additional adverse patient effects were reported.
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Manufacturer Narrative
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This product has not been returned to boston scientific, and as a result, laboratory analysis could not be conducted.The associated investigation determined that the details of the event suggest the possibility that the patient twiddled the device system.
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Search Alerts/Recalls
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