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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 01/01/2015
Event Type  Injury  
Event Description

It was reported that the vns patient was experiencing pain at the electrode site and a lead pulling sensation. The physician observed that the patient¿s generator had migrated lower down the patient¿s chest and that the lead was protruding at the neck. The tension on the lead could be visualized from the neck to the clavicle. It was noted that the patient was very thin. X-rays were provided to the manufacturer for review and found to be unremarkable. The patient underwent surgery on (b)(6) 2015 and the surgeon noted that no suture was securing the generator. The surgeon stated that the suture either dissolved or had broken. The surgeon elected to replace the generator prophylactically and implanted the replacement generator higher up the patient¿s chest.

 
Event Description

It was reported that diagnostics were taken immediately before replacement of device and the impedance was good with a value of 2709 ohms. Diagnostics were taken after the device was replaced and the new device was connected to the patient's current lead. Diagnostics were taken once the new generator was implanted and the impedance was good with a value of 2546 ohms.

 
Manufacturer Narrative

 
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Brand NamePULSE GEN MODEL 103
Type of DeviceGENERATOR
Manufacturer (Section D)
CYBERONICS INC
100 cyberonics blvd
houston TX 77058
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 Key4654528
Report Number1644487-2015-04358
Device Sequence Number1
Product CodeLYJ
Report Source Manufacturer
Source Type Health Professional,Company Representative
Reporter Occupation
Type of Report Initial,Followup
Report Date 03/11/2015
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received04/02/2015
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? No
Device Operator LAY USER/PATIENT
Device EXPIRATION Date04/30/2012
Device MODEL Number103
Device LOT Number2656
Was Device Available For Evaluation? No
Is The Reporter A Health Professional? Yes
Event Location Other
Date Manufacturer Received04/30/2015
Was Device Evaluated By Manufacturer? Device Not Returned To Manufacturer
Date Device Manufactured05/04/2010
Is The Device Single Use? Yes
Is this a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial

Patient TREATMENT DATA
Date Received: 04/02/2015 Patient Sequence Number: 1
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