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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: CYBERONICS, INC. PULSE GEN MODEL 102 GENERATOR

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CYBERONICS, INC. PULSE GEN MODEL 102 GENERATOR Back to Search Results
Model Number 102
Event Date 01/25/2013
Event Type  Injury  
Event Description

Reporter indicated that the patient was experiencing painful and erratic stimulation across her chest where the lead is located and also across her neck and down the left side of her chest and arm. It was also reported to also occur at times when she turns her neck too far in certain positions. It was reported that the patient's painful stimulation was a gradual increase over time and did not start immediately. The physician indicated in notes that the vns may be broken. The patient's device was programmed off and the pain resolved. The magnet mode stimulation was left on and the patient indicated that the pain still occurred when the magnet was used. It was reported that the patient was to follow-up with physician to see if lowering device settings would resolve the pain or if surgery was required. Device diagnostics were performed and were within normal limits. X-rays were taken and sent to device manufacturer for review. There were no gross lead fractures that were visualized; however, the presence of an unpronounced lead discontinuity cannot be ruled out. Further follow-up revealed that the patient has been scheduled for system replacement; however, surgery has not occurred to date.

 
Event Description

Further follow-up revealed that the patient underwent generator replacement surgery on (b)(6) 2013. It was reported that the surgeon did not proceed with a full generator and lead revision and that the generator was replaced prophylactically. The new generator was placed back on the patient's right side due to the patient's pacemaker on the left side; however, a new pocket was created. The surgeon coiled and placed the lead in a pocket near the generator. It was reported that the surgeon feels that the patient's pain will no longer be an issue now that the lead has more flexibility, with less pulling across the patient's chest. The generator was programmed back to on at lower settings than previous and the patient did not experience any pain from the device stimulation. An implant card was received confirming that the generator was replaced prophylactically on (b)(6) 2013. The lead impedance with the new generator and old lead was "ok". Attempts to have the generator returned to device manufacturer are underway; however, the device has not been received to date.

 
Manufacturer Narrative

 
Event Description

The generator was discarded by the explanting facility and will not be returned to device manufacturer for analysis.

 
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Brand NamePULSE GEN MODEL 102
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 Key2972914
Report Number1644487-2013-00471
Device Sequence Number1
Product CodeLYJ
Report Source Manufacturer
Source Type Health Professional,User facility,Company Representative
Reporter Occupation
Type of Report Initial,Followup,Followup
Report Date 01/25/2013
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received02/21/2013
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? No
Device Operator LAY USER/PATIENT
Device EXPIRATION Date05/31/2009
Device MODEL Number102
Device LOT Number017084
Was Device Available For Evaluation? No
Is The Reporter A Health Professional? Yes
Event Location Other
Date Manufacturer Received06/12/2013
Was Device Evaluated By Manufacturer? Device Not Returned To Manufacturer
Date Device Manufactured06/18/2007
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: 02/21/2013 Patient Sequence Number: 1
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