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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 11/13/2014
Event Type  Malfunction  
Event Description

The explanting facility did not discard the devices. The explanted products and opened but unused generator were returned to the manufacturer for analysis. No abnormal performance or any other type of adverse condition was found with the explanted and unused generators. The devices performed according to functional specifications. Analysis of the returned lead confirmed discontinuity of negative quadfilar coil in the body region. It is believed that stimulation was present for a certain period of time as evidenced by the presence of metal pitting. Abraded openings were observed on both the outer and inner tubing near the break area. The abraded openings found on the (-) unmarked connector pin inner silicone tubing and the cut ends that were made during the explanted process most likely provided the leakage path for the dried remnants of what appeared to have once been body fluids inside the inner silicone tubing.

 
Manufacturer Narrative

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

 
Event Description

The explanting facility discarded the explanted devices; therefore, no analysis can be performed.

 
Event Description

It was reported that the vns patient was scheduled for generator replacement surgery on (b)(6) 2014 due to end of service. Pre-operative system diagnostic results showed lead impedance within normal limits (dcdc ¿ 2). After the patient¿s generator was replaced, the replacement generator was tested with the existing lead and diagnostic results revealed high impedance (impedance value -10,000 ohms). The lead was replaced and another generator was implanted due to device compatibility. It was noted that the surgeon handled the patient¿s lead somewhat roughly prior to its replacement. Operative notes were received indicating that the surgeon observed damage to the lead during the procedure so the lead was also replaced. The explanted devices and the opened but unused generator have not been returned to date.

 
Manufacturer Narrative

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

 
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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 Key4326527
Report Number1644487-2014-03298
Device Sequence Number1
Product CodeLYJ
Report Source Manufacturer
Source Type Health Professional,Company Representative
Reporter Occupation HEALTH PROFESSIONAL
Type of Report Initial,Followup,Followup
Report Date 11/13/2014
1 Device Was Involved in the Event
0 PatientS WERE Involved in the Event:
Date FDA Received12/12/2014
Is This An Adverse Event Report? No
Is This A Product Problem Report? Yes
Device Operator LAY USER/PATIENT
Device EXPIRATION Date10/31/2001
Device MODEL Number300-20
Device LOT Number30012C
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 Received02/10/2015
Was Device Evaluated By Manufacturer? Yes
Date Device Manufactured10/12/1999
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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