Model Number 303-30 |
Device Problems
Corroded (1131); Fracture (1260)
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Patient Problem
No Known Impact Or Consequence To Patient (2692)
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Event Date 01/20/2017 |
Event Type
malfunction
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Event Description
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Clinic notes mentioned that high impedance was observed on a patient's device.The patient's device was not programmed off during the clinic visit, per the patient's request.The patient was referred for revision surgery.No additional relevant information has been received to date.No surgical intervention has occurred to date.
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Event Description
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The patient underwent lead and generator replacement surgery due to the high impedance.The company representative present at the surgery indicated that the generator, which had been implanted 2 years prior, was the cause of the high impedance since the lead was initially replaced but did not resolve the high impedance.The explanted products have not been received by the manufacturer to date.No additional relevant information has been received to date.
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Event Description
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The explanted lead and generator were received by the manufacturer, but analysis has not been approved on the devices to date.No additional relevant information has been received to date.
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Event Description
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Analysis was approved for the generator.When received, the data was downloaded from the generator and reviewed.On (b)(6) 2017, a >25% increase in impedance was observed.The impedance value increased from normal impedance to high impedance.The next >25% change in impedance was observed on the date of explant from high impedance to normal impedance.The generator was interrogated, and system diagnostic tests were performed and returned results within the normal limits, indicating that there were no impedance issues with the generator.The generator performed according to functional specifications.Analysis was also approved for the lead.The lead was returned for analysis in two pieces.Three set screw marks were seen on the connector pin providing evidence that proper contact between the set screw and the connector pin existed at least once.A lead break was identified in the positive coil, but the fracture mechanism could not be determined.Microscopy images of the positive coil show evidence of pitting at the lead break location.No additional relevant information has been received to date.
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Search Alerts/Recalls
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