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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 10/22/2015
Event Type  Injury  
Manufacturer Narrative

 
Event Description

It was reported that the vns patient was referred for surgery as the patient's device was unable to be interrogated due to end of service. A battery life calculation using the available programming history showed - 10 years remaining. Follow-up revealed that the patient's device had migrated deep into the armpit of the patient and that the device was unable to be interrogated. It was noted that the patient's device was always difficult to locate. The physician's office stated that it was unknown if the device was actually at end of service. Trauma or any other external/contextual factors were not believed to have caused or contributed to the event. It is unknown whether a non-absorbable suture was used to secure the generator. The patient was referred for surgery but no known surgical interventions have occurred to date.

 
Event Description

New information was received stating that the patient underwent a generator explant and replacement. Follow up with the treating neurologist indicated that he believed the inability to communicate with the device was due to the migration of the generator. The neurologist stated that he does not believe the lead was replaced and indicated that the new generator is functioning properly. Requests for additional relevant information from the surgeon have been unsuccessful to date. Requests to obtain the explanted generator for product analysis have been unsuccessful to date.

 
Event Description

It was confirmed that only the patient's generator was replaced during the surgery due to migration. Product return attempts have been unsuccessful 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 Key5249128
Report Number1644487-2015-06557
Device Sequence Number1
Product CodeLYJ
Report Source Manufacturer
Source Type COMPANY REPRESENTATIVE,HEALTH
Reporter Occupation
Type of Report Initial,Followup,Followup
Report Date 10/30/2015
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received11/25/2015
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? No
Device Operator LAY USER/PATIENT
Device EXPIRATION Date03/31/2015
Device MODEL Number103
Device LOT Number202541
Was Device Available For Evaluation? No
Is The Reporter A Health Professional? Yes
Was the Report Sent to FDA?
Event Location Other
Date Manufacturer Received06/28/2016
Was Device Evaluated By Manufacturer? Device Not Returned To Manufacturer
Date Device Manufactured04/26/2013
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: 11/25/2015 Patient Sequence Number: 1
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