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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: CYBERONICS, INC. PULSE GEN MODEL 101 GENERATOR

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CYBERONICS, INC. PULSE GEN MODEL 101 GENERATOR Back to Search Results
Model Number 101
Event Date 04/02/2001
Event Type  Malfunction  
Event Description

Analysis of the returned lead portion was completed. The abraded openings found on the outer silicone tubing, most likely provided the leakage path for the dried remnants of what appeared to have once been body fluids inside the outer silicone tubing. There were no other product-related issues observed. Note that since the electrode array section was not returned for analysis, an evaluation and resulting commentary cannot be made on that portion of the lead.

 
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 or serious injury.

 
Event Description

It was reported that during prophylactic generator replacement surgery on (b)(6) 2014, the vns patient¿s replacement generator was tested with the existing lead and showed high impedance. The lead pin was reinserted into the generator header and the high impedance condition had resolved. Abrasions were noted on the patient¿s lead. The surgeon elected to replace the lead during the procedure. Pre-operative diagnostics did not reveal any issues. The explanted devices were returned to the manufacturer for analysis. Analysis of the generator concluded that no abnormal performance or any other type of adverse condition was found. Analysis of the returned lead portion is currently underway.

 
Manufacturer Narrative

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

 
Manufacturer Narrative

Age at time of event; corrected data: the initial mdr inadvertently did not provide the correct patient age. Date of event; corrected data: the initial mdr inadvertently did not provide the correct event date. Brand name; corrected data: the initial mdr inadvertently did not provide the correct suspect device for the event. Type of device, name; corrected data: the initial mdr inadvertently did not provide the correct suspect device for the event. Model #, serial #, lot#, expiration date; corrected data: the initial mdr inadvertently did not provide the correct suspect device for the event. Operator of device; corrected data: the previously submitted mdr inadvertently did not provide the correct operator of the device for the event. Device manufacture date; corrected data: the initial mdr inadvertently did not provide the correct suspect device for the event. Evaluation codes, methods, results, conclusions; corrected data: the previously submitted mdr's inadvertently did not provide the correct evaluation coding for the event. Additional manufacturer narrative and/or corrected data; corrected data: the previously submitted mdr inadvertently stated a device failure was suspected.

 
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Brand NamePULSE GEN MODEL 101
Type of DeviceGENERATOR
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 Key4394376
Report Number1644487-2015-03552
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 12/08/2014
1 Device Was Involved in the Event
0 PatientS WERE Involved in the Event:
Date FDA Received01/07/2015
Is This An Adverse Event Report? No
Is This A Product Problem Report? Yes
Device Operator HEALTH PROFESSIONAL
Device EXPIRATION Date01/31/2002
Device MODEL Number101
Device LOT Number1988
Was Device Available For Evaluation? Device Returned To Manufacturer
Date Returned to Manufacturer12/16/2014
Is The Reporter A Health Professional? Yes
Event Location Other
Date Manufacturer Received02/05/2015
Was Device Evaluated By Manufacturer? Yes
Date Device Manufactured01/22/2001
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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