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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
Device Problem Adverse Event Without Identified Device or Use Problem
Event Date 10/04/2017
Event Type  Injury  
Manufacturer Narrative

Device evaluation is not necessary because the reported event of migration has been determined to not be related to vns therapy.

 
Event Description

Report received from clinic notes that a patient was seen in the clinic and her generator was easily palpable in the left chest and axilla. The generator was reportedly extremely mobile and could be flipped over under the skin from side to side. Further information was received that the patient was scheduled to get a generator replacement with the intention of providing the patient with a new generator and correcting the migrated device at the same time. The patient's current generator battery was reportedly depleting, so the neurologist indicated it would be good to replace the device. It was also reported that the migration was needed because there was concern that the flipping of the generator would damage the lead wire. No surgical intervention has occurred to date and no further relevant information has been received.

 
Event Description

Further information was received that the generator replacement and pocket revision had occurred. The generator was disconnected from the lead and explanted. Fibrotic tissue at the generator site was seen during the surgery and removed to make room for the new pocket. A new pocket under the clavicle was created and the new generator was implanted and anchored to this pocket. The surgeon did not note the cause of the migration. Follow-up with the original surgeon was unsuccessful and it was not determined whether non-absorbable sutures were used at the initial implant. No further relevant information has been received to date.

 
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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 Key6993054
Report Number1644487-2017-04713
Device Sequence Number1
Product CodeLYJ
Report Source Manufacturer
Source Type COMPANY REPRESENTATIVE,HEALTH
Reporter Occupation
Type of Report Initial
Report Date 12/05/2017
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received11/01/2017
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? No
Device Operator LAY USER/PATIENT
Device EXPIRATION Date09/30/2011
Device MODEL Number103
Device LOT Number201282
Was Device Available For Evaluation? No Answer Provided
Is The Reporter A Health Professional? Yes
Was the Report Sent to FDA?
Event Location Other
Date Manufacturer Received11/10/2017
Was Device Evaluated By Manufacturer? No
Date Device Manufactured12/03/2009
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: 11/01/2017 Patient Sequence Number: 1
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