Model Number 3772 |
Device Problems
Failure to Charge (1085); Wireless Communication Problem (3283)
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Patient Problem
Inadequate Pain Relief (2388)
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Event Date 10/09/2020 |
Event Type
Injury
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Manufacturer Narrative
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Date of event and implant date is estimated.The results/method and conclusion codes along with investigation results will be provided on the final report.
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Event Description
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It was reported that the implantable pulse generator was unable to be charged resulting in the patient having a loss of effective therapy.Patient was charging the device as recommended prior to the device charging failure.The device was explanted, and a new device was implanted.There were no complications during the procedure.Patient was stable.
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Manufacturer Narrative
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The reported event of no communication /ipg inoperable was confirmed.At receipt, the ipg would not communicate with lab utilities due to a depleted battery.The battery was recovered and the ipg communicated, charged, but did not pass autotest due to two broken feed through wires.The broken feed through wire damage is consistent with damage that was sustained during the explant process.Ppe was unable to determine the root cause of reported event.
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Manufacturer Narrative
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The reported event of no communication /ipg inoperable was confirmed.At receipt, the ipg would not communicate with lab utilities due to a depleted battery.The battery was recovered and the ipg communicated and charged.Ppe was unable to determine the root cause of reported event.Corrected data: h6: investigations findings code 3252 - fracture problem has been removed from this report and was added in error.Investigation conclusions code 22 - known inherent risk of device has been removed from this report and was added in error.H10: manufacturer narrative has been corrected.
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Search Alerts/Recalls
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