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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: CYBERONICS, INC. BIPOL LEAD MODEL 300

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CYBERONICS, INC. BIPOL LEAD MODEL 300 Back to Search Results
Model Number 300-20
Event Date 10/20/2014
Event Type  Malfunction  
Event Description

On (b)(6) 2014 it was reported that the patient had high impedance during a system and normal mode diagnostics test. It was also noted that the patient¿s battery is near end of service. The patient was referred for a full revision surgery. Although surgery is likely, it has not occurred to date.

 
Event Description

On (b)(6) 2015 it was reported that the patient underwent a full revision surgery due to high impedance and end of service. It was reported that the generator was unable to be interrogated due to end of service. The generator and lead were received for product analysis on 02/10/2015. Product analysis is underway and has not yet been completed.

 
Manufacturer Narrative

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

 
Manufacturer Narrative

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

 
Event Description

On 02/25/2015 product analysis was competed on the generator. The generator was found to be at end of service and was determined to be the result of normal battery depletion. Based on the electrical test results, the device exhibited current consumption rates that are within specification, thereby demonstrating normal battery depletion to an end-of-service condition. A battery life estimation resulted in 3. 00 years remaining before the eri flag would be set. However, an incomplete programming history (8. 5-year gap) indicates the estimation does not use all the data required to make an accurate estimation. Therefore, the electrical performance of the generator, as measured in the product analysis lab, will be used to conclude that no anomalies exist and the eos condition is an expected event. The pulse generator module performed according to functional specifications; there was no condition noted during the product analysis evaluation that would suggest any anomaly with the device. Product analysis on the lead was completed on 03/04/2015. Which confirmed discontinuity of the positive quadfilar coil in the body region of the returned lead portions; also observed abraded openings of the inner tubing near the break location. A break was identified in the positive coil at two locations. Scanning electron microscopy images of the positive coil end, positive coil segment, and strands segments show that pitting or electro-etching conditions have occurred at the break locations. However, due to metal dissolution and/or surface contamination the fracture mechanism cannot be ascertained. The inner silicone tubing of the lead coils has abraded openings at the ends. The lead assembly has dried remnants of what appear to have once been body fluids 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. Since a portion of the lead (including the unmarked connector and the electrode array) was not returned for analysis, an evaluation and resulting commentary cannot be made on that portion of the lead.

 
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Brand NameBIPOL LEAD MODEL 300
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 Key4242379
Report Number1644487-2014-02983
Device Sequence Number1
Product CodeMUZ
Report Source Manufacturer
Source Type Health Professional,Company Representative
Reporter Occupation HEALTH PROFESSIONAL
Type of Report Initial,Followup,Followup
Report Date 10/20/2014
1 Device Was Involved in the Event
0 PatientS WERE Involved in the Event:
Date FDA Received11/11/2014
Is This An Adverse Event Report? No
Is This A Product Problem Report? Yes
Device Operator LAY USER/PATIENT
Device EXPIRATION Date09/30/2002
Device MODEL Number300-20
Device LOT Number739
Was Device Available For Evaluation? Device Returned To Manufacturer
Date Returned to Manufacturer02/10/2015
Is The Reporter A Health Professional? Yes
Event Location Other
Date Manufacturer Received02/25/2015
Was Device Evaluated By Manufacturer? Yes
Date Device Manufactured09/18/2000
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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