Model Number 3501 |
Device Problems
High impedance (1291); Failure to Sense (1559); Connection Problem (2900)
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Patient Problems
No Known Impact Or Consequence To Patient (2692); No Code Available (3191)
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Event Date 06/24/2020 |
Event Type
Injury
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Manufacturer Narrative
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As no further information concerning this report is expected, our investigation is complete.This investigation will be updated should further information be provided.
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Event Description
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It was reported that this system exhibited out of range shock impedance measurements and no sensing is all vectors.X rays were obtained which confirmed that the electrode's terminal pin was completely removed from the subcutaneous implantable cardioverter defibrillator (s-icd) header.The electrode position looked to be maintained.A revision procedure will occur next week.A boston scientific technical services consultant documented and discussed the clinical observations with the caller.No adverse patient effects were reported.
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Manufacturer Narrative
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As no further information concerning this report is expected, our investigation is complete.This investigation will be updated should further information be provided.The 3191 code was utilized due to the surgery that occurred.
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Event Description
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It was reported that a revision procedure was subsequently performed and the associated device was removed from service and replaced.This electrode remains in service.No additional adverse patient effects were reported.
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Search Alerts/Recalls
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