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Model Number 302-30 |
Device Problem
Fracture (1260)
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Patient Problem
No Known Impact Or Consequence To Patient (2692)
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Event Date 02/27/2017 |
Event Type
malfunction
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Event Description
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Clinic notes reported that a patient was referred for full revision surgery due to high impedance.The high impedance was identified via diagnostic test, which indicated that the device was providing a lower output current than was programmed.The physician requested x-rays of the patient's device.The x-rays were sent to the manufacturer; however, since x-ray viewer software did not accompany the images, the x-rays could not be reviewed by the manufacturer.The patient underwent full revision surgery due to battery depletion and high impedance.The explanted devices were planned for return to the manufacturer, but 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; however, analysis has not been approved to date.No additional relevant information has been received to date.
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Event Description
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Analysis was approved on the generator.When received, the data was downloaded from the generator and reviewed.A >25% increase in impedance was observed 6 months prior to explant.Since the impedance values before and after the observed increase indicated high impedance, it is likely the high impedance existed prior to the date that the change was observed.No visual anomalies were identified with the generator.Testing was performed on the internal circuitry of the generator, and the device performed according to functional specifications.Analysis was also approved for the lead.A portion of the lead assembly was returned in one piece, but the electrodes were not returned and thus an assessment cannot be made on that portion of the lead.Five sets of set screw marks were seen on the connector pin providing evidence that proper contact between the lead and generator existed 4 times; one set of the set screw marks was located at the end tip suggesting that the lead connector pin was not completely inserted at one point in time.A lead fracture was not observed in the returned portion of the lead.No additional relevant information has been received to date.
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Search Alerts/Recalls
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