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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: CYBERONICS, INC. LEAD MODEL 302

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CYBERONICS, INC. LEAD MODEL 302 Back to Search Results
Model Number 302-20
Event Date 08/14/2012
Event Type  Malfunction  
Event Description

Product analysis for the explanted generator was completed on (b)(6) 2012. The pulse generator was explanted/returned due to prophylactic replacement. A comprehensive automated electrical evaluation showed that the pulse generator performed according to functional specifications. There were no performance or any other type of adverse conditions found with the pulse generator. A battery life calculation on (b)(6) 2012 indicated 6. 49 years remaining.

 
Event Description

Additional information was received indicating that x-rays were taken; however, the device was not visible. Attempts to obtain new images were unsuccessful. The patient's increase in seizures was attributed to the high impedance. The patient underwent revision on (b)(6) 2012. The new device was successfully implant and verified to be working properly. The generator was replaced prophylactically. After re-implant, the patient responded to treatment. The lead and generator were received on (b)(6) 2012. Product analysis for the explanted lead showed that 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. Four sets of setscrew marks were seen on the connector pin, providing evidence that proper contact between the setscrew and the lead pin existed at least once. 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 of when this occurred is unknown. 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. White deposits were identified on the connector boot in the vicinity of the ring/backfill interface. Abrasions were identified on the connector boot. The outer silicone tubing has what appear to be abrasions/imprints. The outer silicone tubing appears to have been compressed at three locations. Abrasions most likely caused by the presence of a tie-down were identified; the outer silicone tubing is cut open at approximately 33 cm from boot. No obvious damage to the lead coils or the inner tubing was noted at this location. The outer silicone tubing has what appear to be internal abrasions at multiple locations. Abrasions were identified on the silicone tubing of the lead coils. The lead assembly has remnants of what appears to be body fluids inside the inner and the outer silicone tubing. No obvious point of entrance was noted other than the identified tubing opening and the end of the returned lead portion. No discontinuities were identified within 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.

 
Manufacturer Narrative

Analysis of programming history.

 
Event Description

On (b)(6) 2012, it was reported that normal mode and system diagnostics for a vns patient indicated high impedance. Diagnostics were repeated with the same results. The device subsequently programmed off. The physician requested a new generator due to the fact that this generator was implanted in 2008. The event was reported to be continuous, of moderate severity, and possibly related to stimulation. Device parameters were changed as intervention. It was also noted that the patient had an increase in seizures over the previous seizure rate. The patient reportedly has generalized tonic-clonic seizures and atonic seizures. The patient's settings and diagnostics from this date were provided. Additional information was received that x-rays were taken and would be provided for manufacturer review; however, they have not been received to date. The patient had not had any fall, injury or manipulation of her vns lead that could be attributed to the high impedance. The increase in seizures was over thee pre-vns seizure rate at baseline rate two months prior. The physician attributed the loss of therapy to the high impedance. Adjustments to mediation were made to treat seizures and to preclude a serious injury. Surgery is likely, but has not occurred.

 
Manufacturer Narrative

Device failure is suspected but did not cause or contribute to a death.

 
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Brand NameLEAD MODEL 302
Type of DeviceLEAD
Manufacturer (Section D)
CYBERONICS, INC.
100 cyberonics blvd
houston TX 77058 770
Manufacturer (Section G)
CYBERONICS, INC.
100 cyberonics blvd
suite 600
houston TX 77058
Manufacturer Contact
nydia herzog
100 cyberonics blvd
suite 600
houston , TX 77058
2812287200
MDR Report Key2744314
Report Number1644487-2012-02323
Device Sequence Number1
Product CodeLYJ
Report Source Manufacturer
Source Type Health Professional,Company Representative
Reporter Occupation
Type of Report Initial,Followup,Followup
Report Date 08/15/2012
1 Device Was Involved in the Event
0 PatientS WERE Involved in the Event:
Date FDA Received09/13/2012
Is This An Adverse Event Report? No
Is This A Product Problem Report? Yes
Device Operator LAY USER/PATIENT
Device EXPIRATION Date04/30/2011
Device MODEL Number302-20
Device LOT Number200788
Was Device Available For Evaluation? Device Returned To Manufacturer
Date Returned to Manufacturer10/29/2012
Is The Reporter A Health Professional? Yes
Event Location Other
Date Manufacturer Received11/19/2012
Was Device Evaluated By Manufacturer? Yes
Date Device Manufactured04/17/2008
Is The Device Single Use? Yes
Is this a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial

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