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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 04/15/2013
Event Type  Malfunction  
Event Description

On (b)(6) 2013 it was reported that a lead break was observed for the vns patient. It was stated that high lead impedance was observed on (b)(6) 2013. The patient¿s device was turned off at that time and x-rays were performed. It was stated that the hospital will not release the x-rays for review. The patient falls during seizures but there has been no obvious trauma that may have resulted in a lead break. The patient was referred for surgery. Although surgery is likely, it has not occurred to date.

 
Manufacturer Narrative

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

 
Event Description

On (b)(6) 2013 it was reported that the patient had undergone surgery on (b)(6) 2013 and it was found that the cause of the high impedance was that the lead pin was not fully inserted into the header of the generator.

 
Manufacturer Narrative

Observed during surgery, lead pin not fully inserted past the connector block of generator. Additional information was received which changes the product the report is reported on.

 
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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
nydia herzog
100 cyberonics blvd
suite 600
houston , TX 77058
2812287200
MDR Report Key3149567
Report Number1644487-2013-01698
Device Sequence Number1
Product CodeLYJ
Report Source Manufacturer
Source Type Foreign,Health Professional,Company Representative
Reporter Occupation
Type of Report Initial,Followup
Report Date 05/15/2013
1 Device Was Involved in the Event
0 PatientS WERE Involved in the Event:
Date FDA Received06/06/2013
Is This An Adverse Event Report? No
Is This A Product Problem Report? Yes
Device Operator LAY USER/PATIENT
Device EXPIRATION Date09/30/2014
Device MODEL Number103
Device LOT Number202252
Was Device Available For Evaluation? No
Is The Reporter A Health Professional? No
Event Location Other
Date Manufacturer Received07/18/2013
Was Device Evaluated By Manufacturer? Device Not Returned To Manufacturer
Date Device Manufactured09/26/2012
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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