Model Number 1458QL/86 |
Device Problem
Insufficient Information (3190)
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Patient Problem
No Information (3190)
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Event Type
malfunction
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Manufacturer Narrative
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This product is registered as a combination product.The results of the investigation are inconclusive since the device was not returned for analysis.Based on the information received, the cause of the reported incident could not be conclusively determined.
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Event Description
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It was reported that the left ventricular lead implanted (b)(6) 2020 was marked as out of service on the same day (b)(6) 2020 during a routine insertion of a pacing electrode for ventricular pacing and insertion of an implantable cardiac defibrillator.It is not know whether this lead was capped and remained implanted or was explanted.No additional information was provided.Further information was requested but was not available.
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Event Description
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It was reported that the left ventricular lead implanted (b)(6), 2019 was marked as out of service on the same day (b)(6), 2019 during a routine insertion of a pacing electrode for ventricular pacing and insertion of an implantable cardiac defibrillator.No additional information was provided.Further information was requested but was not available.
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Manufacturer Narrative
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Should have been (b)(6), 2019 rather than (b)(6), 2020.
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Search Alerts/Recalls
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