Model Number 302-20 |
Device Problems
Corroded (1131); Fracture (1260); Mechanical Problem (1384); Premature End-of-Life Indicator (1480)
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Patient Problem
No Known Impact Or Consequence To Patient (2692)
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Event Date 04/27/2015 |
Event Type
malfunction
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Event Description
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Report received that a generator battery depleted more quickly than anticipated.The generator was to be returned to the manufacturer for analysis.The generator has not been received to date and no other relevant information has been obtained.
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Event Description
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Further information was received from the nurse that the initial report of a generator not having the expected longevity was inaccurate.It was reported that the issue was actually a lead that did not function as expected.Further information indicated that high impedance was found on the patient's lead and first generator.This generator was replaced with a second generator on a later date, but the lead remained implanted.System diagnostics were run and high impedance was still reportedly present after this generator replacement.The second generator and lead were later replaced with a new vns system.The second generator and connected lead were returned to the manufacturer, but have not been received to date.The programming history on the first generator was not available at the time of the high impedance.There was no programming history available for the second generator.No further relevant information has been received to date.
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Manufacturer Narrative
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Corrected data, device manufacture date: supplemental mdr #1 inadvertently did not include the manufacture date for the lead.
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Event Description
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Further information was received that the patient's most recent generator and lead were received by the manufacturer.Analysis has not been completed to date.It was also reported that the explant date was initially reported incorrectly.The correct date was provided.No further relevant information has been obtained to date.
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Event Description
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Further information was received that product analysis was completed on the generator.There were no visual anomalies observed.All diagnostic tests performed on the generator showed that lead impedance and current delivered was normal.The generator performed according to all functional and electrical specifications.The data from the generator provided measured impedance values throughout the time the generator was connected to the lead.This data showed that high impedance was present when the generator was first implanted but had resolved at a later date.After it had resolved, high impedance returned indicating the high impedance may have been intermittent.Product analysis was later completed on the lead.The lead was returned in three pieces, but portions of the lead were not returned and an evaluation could not be made on that part.Two sets of set screw marks were seen on the connector pin providing evidence that proper contact was made between the set screw and connector pin.Abrasions were noted on the silicone tubing of the lead coils past the electrode bifurcation.Abrasions were noticed along the outer silicone tubing at multiple locations.Abrasions caused by tie-downs were also noted.These abrasions were likely caused by normal wear and not the surgical procedure.A suspected coil break was identified in the positive coil past the anchor tether.A single broken strand was identified in the positive cold prior to the break location.Scanning electron microscopy images of the positive coil break and single broken strand show that pitting or electro-etching conditions have occurred at the break location.Due to mechanical distortion and/or metal dissolution, the fracture mechanism of the coil could not be determined.Other than the above mentioned observations and typical wear and explant related observations, no other anomalies were identified in the returned lead.No further relevant information has been obtained to date.
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Search Alerts/Recalls
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