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CYBERONICS, INC. LEAD MODEL 302 Back to Search Results
Model Number 302-20
Event Date 06/22/2012
Event Type  Malfunction  
Event Description

Product analysis for the explanted generator and lead was approved on (b)(6) 2012. The near end of service flag was set (n eos = yes) for the generator. The battery was partially depleted and determined to be the result of normal expected battery consumption based on the battery life analysis and electrical test results. The pulse generator module performed according to functional specifications. There were no performance or any other type of adverse conditions found with the pulse generator. Only a section of the lead was returned for product analysis. The lead's electrodes were not returned. Two tie-downs were returned with the lead. Two sets of setscrew marks were seen on the connector pin, providing evidence that contact between the setscrew and the lead pin existed at least once. One of the setscrew marks is located toward the end tip of the connector pin. Also, the connector ring has scratches most likely caused by the canted spring in the pulse generator header during insertion of the lead connector. The exact point in time when this occurred is unknown. Based on the location of the setscrew marks on the connector pin and scratches from the canted spring observed on the connector ring, it is believed that proper contact between the pulse generator "+" and "-" terminals and the lead connector respective contact points (connector ring and connector pin) existed at least once. The lead connector has partial detachment at the ring/backfill interface. The reason for this condition is unknown. No adverse effect was identified on the device performance as a result of this condition. Abrasions were identified on the connector boot. Abrasions were identified on the outer silicone tubing at multiple locations. White deposits were identified on the outer silicone tubing at various locations. The lead assembly has remnants of what appears to be dry body fluid inside the inner and the outer silicone tubing. No obvious point of entrance was noted other than the identified tubing openings and the end of the returned lead portion. An energy dispersive spectrometry analysis performed on a sample of the white deposits identified si, p, ca, na, and mg as the composition for the substance. The exact reason for the presence of the substance is unknown. The lead assembly was returned for analysis due to high impedance. The reported high impedance allegation was not verified within the returned lead portion. Note that since the electrode array portion was not returned for analysis, an evaluation and resulting commentary cannot be made on that portion of the lead. Other than typical wear and explant related observations, no anomalies were identified in the returned lead portion.

Manufacturer Narrative

Only a portion of the lead was returned for analysis which did not reveal any anomalies. Device failure is suspected in the lead portion not returned, but did not cause or contribute to a death or serious injury.

Event Description

On (b)(6) 2012, it was reported that a patient underwent total revision on this date and that the explanted devices would be returned to the manufacturer. The generator was replaced due to end of service, and the lead was replaced due to high impedance. A manufacturer's consultant also indicated that these physicians may not be willing to provide additional information. On (b)(6) 2012, the explanted generator and lead were returned and are currently undergoing product analysis. A returned product form received on (b)(4) 2012, indicated that the lead came out in pieces and the largest piece was returned. A battery life calculation was performed on (b)(4) 2012. The results indicated negative years to eri = yes. On (b)(6) 2012, it was reported that the physician would not provide any additional information regarding these events.

Manufacturer Narrative

Analysis of programming history. Device failure is suspected, but did not cause or contribute to a death or serious injury.

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Brand NameLEAD MODEL 302
Type of DeviceLEAD
Manufacturer (Section D)
100 cyberonics blvd
houston TX 77058 770
Manufacturer (Section G)
100 cyberonics blvd
suite 600
houston TX 77058
Manufacturer Contact
nydia herzog
100 cyberonics blvd
suite 600
houston , TX 77058
MDR Report Key2647472
Report Number1644487-2012-01718
Device Sequence Number1
Product CodeLYJ
Report Source Manufacturer
Source Type Other,Health Professional,Company Representative
Reporter Occupation
Type of Report Initial,Followup
Report Date 06/22/2012
1 Device Was Involved in the Event
0 PatientS WERE Involved in the Event:
Date FDA Received07/10/2012
Is This An Adverse Event Report? No
Is This A Product Problem Report? Yes
Device Operator LAY USER/PATIENT
Device EXPIRATION Date12/31/2005
Device MODEL Number302-20
Device LOT Number9771
Was Device Available For Evaluation? Device Returned To Manufacturer
Date Returned to Manufacturer06/29/2012
Is The Reporter A Health Professional? No
Event Location Other
Date Manufacturer Received07/30/2012
Was Device Evaluated By Manufacturer? Yes
Date Device Manufactured12/16/2003
Is The Device Single Use? Yes
Is this a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial