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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: CYBERONICS, INC. PULSE GEN MODEL 105 GENERATOR

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CYBERONICS, INC. PULSE GEN MODEL 105 GENERATOR Back to Search Results
Model Number 105
Event Date 01/01/2015
Event Type  Malfunction  
Event Description

It was reported that the patient experienced painful device stimulation at the neck every 5 minutes. Device diagnostics were performed which showed high impedance. The patient was referred to surgeon. There was no known trauma that may have caused or contributed to the high impedance. X-rays were performed and the x-ray review was sent to manufacturer. X-rays do not indicate a lead discontinuity. Surgical office notes dated (b)(6) 2015 not that there is a questionable microscopic lead break and new lead and generator are needed. It was noted that the patient's symptoms are worse at work and stop when the patient is home. No known surgical intervention has been performed to date. Attempts to obtain additional relevant information have been unsuccessful to date.

 
Event Description

Additional information was received stating that the patient's painful stimulation began occurring about four to five months following (b)(6) 2014 generator replacement surgery. X-ray review by the surgeon reported no conclusive results. The lead pin was stated to be fully inserted during the (b)(6) 2014 surgery, as verified on x-rays, and no lead fracture was visualized. Device diagnostics taken after this (b)(6) 2014 revision were stated to be normal. The surgeon also reported he did not believe the patient's neck pain was related to vns. No known surgical interventions have occurred to date.

 
Event Description

Additional information was received that the patient underwent a prophylactic generator replacement surgery (b)(6) 2015. The patient's device was seen to have been programmed off prior to surgery. Pre-operative diagnostics were run and showed normal impedance readings. Thus, only the generator was replaced and incomplete lead pin insertion was believed to be the cause of the previous intermittent high impedance result. Complete pin insertion was verified with the surgeon. A system diagnostic test indicated normal impedance upon being run three times. An implant card was received which confirmed the high impedance as the reason for the generator replacement being scheduled. The explanting facility will not return explanted devices to the manufacturer for analysis; therefore, no analysis can be performed.

 
Manufacturer Narrative

Device failure is suspected, but did not cause or contribute to a death or serious injury.

 
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Brand NamePULSE GEN MODEL 105
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
njemile crawley
100 cyberonics blvd
suite 600
houston , TX 77058
2812287200
MDR Report Key4481386
Report Number1644487-2015-03743
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 01/08/2015
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received02/03/2015
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? Yes
Device Operator LAY USER/PATIENT
Device EXPIRATION Date12/31/2015
Device MODEL Number105
Device LOT Number202808
Was Device Available For Evaluation? No
Is The Reporter A Health Professional? Yes
Event Location Other
Date Manufacturer Received03/12/2015
Was Device Evaluated By Manufacturer? Device Not Returned To Manufacturer
Date Device Manufactured02/05/2014
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: 02/03/2015 Patient Sequence Number: 1
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