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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: CYBERONICS, INC. PULSE GEN MODEL 103 GENERATOR

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CYBERONICS, INC. PULSE GEN MODEL 103 GENERATOR Back to Search Results
Model Number 103
Event Date 01/27/2015
Event Type  Malfunction  
Event Description

It was reported that during generator replacement for end of service, device diagnostics resulted in high impedance with the new generator connected to the existing lead (mfr. Report # 1644487-2015-03930). When the high impedance was observed the surgeon attempted to remove the lead pins from the generator header; however, the surgeon experienced difficulties removing the lead from the generator header. The surgeon then explanted the lead and did not implant the generator. The explanted generator was received for analysis with the lead pin inserted into the generator header. Analysis is underway, but has not been completed to date.

 
Manufacturer Narrative

 
Manufacturer Narrative

(b)(4). Corrected data: the previously submitted mdr inadvertently did not provide the udi number of the suspect device.

 
Event Description

Analysis of the returned generator was completed on 03/03/2015 and it found no obstructions in the header lead cavity or the connector blocks. A bench lead was fully inserted into the generator header and removed with no difficulties. The setscrew was not returned. X-rays of the generator in as-received conditions shows that the negative connector block contains no setscrew. X-rays of the generator after manufacture shows that the setscrew was installed in the negative connector block. The pulse generator battery was found to be in an ifi=no condition. No adverse conditions were found with the pulse generator. Analysis of the lead was reported in manufacturer report # 1644487-2015-03930.

 
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Brand NamePULSE GEN MODEL 103
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 Key4551293
Report Number1644487-2015-03985
Device Sequence Number1
Product CodeLYJ
Report Source Manufacturer
Source Type Foreign,Health Professional,Company Representative
Reporter Occupation
Type of Report Initial,Followup,Followup
Report Date 01/27/2015
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
Device EXPIRATION Date09/30/2016
Device MODEL Number103
Device LOT Number4084
Was Device Available For Evaluation? Device Returned To Manufacturer
Date Returned to Manufacturer02/09/2015
Is The Reporter A Health Professional? Yes
Event Location Other
Date Manufacturer Received04/21/2015
Was Device Evaluated By Manufacturer? Yes
Date Device Manufactured10/09/2014
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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