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U.S. Department of Health and Human Services

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

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CYBERONICS, INC. LEAD MODEL UNKNOWN Back to Search Results
Event Date 12/18/2014
Event Type  Malfunction  
Event Description

It was reported that diagnostics test resulted in high impedance. The patient had undergone battery replacement on (b)(6) 2014. It was reported that the impedance was assessed again on (b)(6) 2015 and that high impedance persisted (>10000 ohms). X-rays were reviewed by the healthcare professional and no abnormal findings were reported. The lead-pin was reported to be fully inserted into the generator¿s connector block. The patient had been implanted with the existing lead in 2004. The generator that was replaced on (b)(6) 2014 was a fully depleted model 102 which could not be interrogated. Surgical revision is planned but it has not occurred to date.

 
Event Description

Additional information was received stating that the vns patient underwent lead replacement surgery on (b)(6) 2015. During the procedure, the surgeon observed damage to the lead. The surgeon believed the damage likely occurred at the patient¿s previous generator replacement surgery on (b)(6) 2014 due to end of service. The replacement lead was tested with the existing generator and diagnostic results showed lead impedance within normal limits. The surgeon stated that the explanted lead will not be returned to the manufacturer for analysis; therefore, no analysis can be performed.

 
Manufacturer Narrative

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

 
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Brand NameLEAD MODEL UNKNOWN
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 Key4547937
Report Number1644487-2015-03973
Device Sequence Number1
Product CodeLYJ
Report Source Manufacturer
Source Type Foreign,Health Professional,Company Representative
Reporter Occupation
Type of Report Initial,Followup
Report Date 02/02/2015
1 Device Was Involved in the Event
0 PatientS WERE Involved in the Event:
Date FDA Received02/26/2015
Is This An Adverse Event Report? No
Is This A Product Problem Report? Yes
Device Operator HEALTH PROFESSIONAL
Was Device Available For Evaluation? No
Is The Reporter A Health Professional? Yes
Event Location Other
Date Manufacturer Received03/27/2015
Was Device Evaluated By Manufacturer? Device Not Returned To Manufacturer
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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