Model Number 302-20 |
Device Problems
Corroded (1131); Fracture (1260); High impedance (1291); Mechanical Problem (1384)
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Patient Problem
No Known Impact Or Consequence To Patient (2692)
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Event Date 12/06/2016 |
Event Type
malfunction
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Event Description
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It was reported that the patient was undergoing generator replacement surgery due to battery depletion.System diagnostic testing were not performed on the generator during pre-op.After the new generator was placed high impedance was observed.The old generator was then attached to the existing lead and the high impedance did not go away.The patient was then closed with the new generator implanted and the generator was turned off.The surgeon intended to rescheduled the patient for lead revision in the future.The explanted generator has not been received to date.X-rays were taken prior to surgery and no obvious lead breaks were observed by the surgeon.These x-rays have not been reviewed by the manufacturer.Further follow-up with the physician's office found that diagnostic testing was performed in the months prior to the surgery and no lead issues were observed.No surgical interventions are known to have occurred to date.No additional relevant information has been received to date.
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Event Description
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The implant card from the generator replacement surgery was received which confirmed that after the new generator was implanted diagnostic tested found high impedance.The explanted generator was received and product analysis was completed.Visual analysis on the explanted generator found that damage to the underside of the set screw which likely occurred when the set screw was loosened during the explant procedure.There was no evidence of dried body fluid or corrosion in the connector block.The explanted generator performed according to functional specifications.
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Event Description
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It was reported that the patient underwent lead replacement surgery.Prior to the lead being replaced the surgeon attempted to reinsert the lead pin several times however the high impedance did not resolve.Therefore it appeared that the high impedance was likely caused by a lead fracture and not a connection issue between the lead pin and generator.The lead was then replaced.The explanted lead has not been received to date.
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Event Description
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The explanted lead was received by the manufacturer and is pending product analysis.
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Event Description
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Analysis was completed on the returned lead.It was noted that the lead was received in 5 portions which included the connector pin and electrodes with one tie down attached.Set screw marks were confirmed on the connector pin which indicated that there was proper connection between the lead pin and generator at one time.Analysis did confirm a lead fraction in the quadfilar coil and the inner tubing appeared to be torn.Scanning electron microscopy found pitting at the fracture which prevented identification of the coil fracture type.The pitting indicated that stimulation was being delivered after the fracture occurred.Continuity checks were performed on the other the lead portions and no other discontinuities were identified.
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Search Alerts/Recalls
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