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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: CYBERONICS INC PULSE GEN MODEL102 PULSE GEN MODEL 102

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CYBERONICS INC PULSE GEN MODEL102 PULSE GEN MODEL 102 Back to Search Results
Model Number 102
Event Date 06/13/2012
Event Type  Injury  
Event Description

Reporter indicated the patient was having some left pectoral pain, but this was not considered a serious injury. It was felt the generator had migrated over the previous 3-4 weeks. The patient had generator replacement surgery performed on (b)(6) 2012. Attempts for return of the explanted generator have been unsuccessful to date.

 
Event Description

Additional manufacturer follow up with the hospital revealed the explanted vns generator was discarded after the surgery.

 
Manufacturer Narrative

Initial reporter, corrected data: the initial mdr report inadvertently listed the incorrect initial reporter. The correct reporter and occupation are provided.

 
Event Description

A manufacturer's implant card was received from the reporter indicating that vns device diagnostics were within normal limits with the resident lead and new vns generator at the (b)(6) 2012 surgery. The implant card indicated the generator was replaced for prophylactic reasons.

 
Event Description

Reporter indicated a patient was experiencing migration of the vns generator into the left axilla, along with painful vns stimulation in the chest. The migration occurred approximately (b)(6) 2012. The patient has also reported the vns lead was migrating, but the reporter confirmed only the generator was migrating. It was also reported the generator was at end of service. However, a battery estimate performed yielded 4 years remaining, indicating end of service is unlikely. The patient had no trauma and did not manipulate the vns. The vns generator was secured with a non-absorbable suture at the initial implant surgery on (b)(6) 2007. Surgery to replace the vns generator is tentatively planned for (b)(6) 2012. Attempts for further information are in progress.

 
Manufacturer Narrative

 
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Brand NamePULSE GEN MODEL102
Type of DevicePULSE GEN MODEL 102
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 Key2648409
Report Number1644487-2012-01734
Device Sequence Number1
Product CodeMUZ
Report Source Manufacturer
Source Type Consumer,Health Professional,Company Representative
Reporter Occupation
Type of Report Initial,Followup,Followup,Followup
Report Date 06/13/2012
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received07/10/2012
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? No
Device Operator LAY USER/PATIENT
Device EXPIRATION Date02/29/2008
Device MODEL Number102
Device LOT Number015227
Was Device Available For Evaluation? No
Is The Reporter A Health Professional? Yes
Event Location Other
Date Manufacturer Received10/02/2012
Was Device Evaluated By Manufacturer? Device Not Returned To Manufacturer
Date Device Manufactured04/18/2006
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: 07/10/2012 Patient Sequence Number: 1
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