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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: CYBERONICS, INC. LEAD MODEL 304

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CYBERONICS, INC. LEAD MODEL 304 Back to Search Results
Model Number 304-20
Event Date 12/01/2014
Event Type  Malfunction  
Event Description

Clinic notes dated (b)(6) 2014 reported that high lead impedance was detected with report of ¿battery failing. ¿ there was mention of ¿scar under electrode¿ and jump in impedance to dcdc ¿ 7. Follow-up with the physician¿s office was performed. It was reported that high impedance was detected on system diagnostic testing. Although surgery is likely, it has not occurred to date.

 
Event Description

Analysis was completed on the explanted generator and lead. The lead fracture was not confirmed in the returned lead portion. Scanning electron microscopy images of the positive coil show that pitting or electro-etching conditions have occurred at the cut/torn end of the coil. Scanning electron microscopy images of the negative coil show that pitting or electro-etching conditions have occurred on the coil surface. Although not conclusive, the most likely cause for the observed pitting conditions is that the generator was not programmed off at the time of explant (generator was still programmed to deliver an output, attempting to deliver therapy through an open electrical load - cut leads). Note that since a portion of the lead was not returned for analysis, an evaluation and resulting commentary cannot be made on that portion of the lead. Other than the above mentioned observations and typical wear and explant related observations, no other anomalies were identified in the returned lead portions. Analysis of the generator revealed that the elective replacement indicator (eri) was set. Based on the electrical test results, the device exhibited current consumption rates that are within specification, thereby demonstrating normal battery depletion to an eri condition. There was no condition noted during the product analysis evaluation that would suggest any anomaly with the device.

 
Manufacturer Narrative

Device failure suspected, but did not cause or contribute to a death or serious injury.

 
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 no returned, but did not cause or contribute to a death or serious injury.

 
Event Description

It was reported that the patient had generator and lead replacement surgery on (b)(6) 2015. The explanted generator and lead were received by the manufacturer for analysis. However, analysis has not been completed to date. The reason for product return was documented by the explant hospital as "non-functioning battery and leads. ".

 
Manufacturer Narrative

 
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Brand NameLEAD MODEL 304
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
njemile crawley
100 cyberonics blvd
suite 600
houston , TX 77058
2812287200
MDR Report Key4521904
Report Number1644487-2015-03874
Device Sequence Number1
Product CodeLYJ
Report Source Manufacturer
Source Type Health Professional,User facility,Company Representative
Reporter Occupation HEALTH PROFESSIONAL
Type of Report Initial,Followup,Followup
Report Date 02/03/2015
1 Device Was Involved in the Event
0 PatientS WERE Involved in the Event:
Date FDA Received02/17/2015
Is This An Adverse Event Report? No
Is This A Product Problem Report? Yes
Device Operator LAY USER/PATIENT
Device EXPIRATION Date08/31/2014
Device MODEL Number304-20
Device LOT Number201536
Was Device Available For Evaluation? Device Returned To Manufacturer
Date Returned to Manufacturer04/08/2015
Is The Reporter A Health Professional? Yes
Event Location Other
Date Manufacturer Received04/30/2015
Was Device Evaluated By Manufacturer? Yes
Date Device Manufactured07/26/2010
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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