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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: CYBERONICS, INC. LEAD MODEL UNKNOWN

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CYBERONICS, INC. LEAD MODEL UNKNOWN Back to Search Results
Event Date 09/08/2014
Event Type  Injury  
Event Description

It was reported that the vns patient was experiencing painful stimulation and went to the er on (b)(6) 2014. The er physician stated that the patient¿s device was ¿misfiring¿. Follow-up revealed that during the er visit, the er physician had concerns of a potential lead break and subsequently disabled the device. The patient was sent for x-rays. Review of the available programming and diagnostic history showed normal diagnostic results through (b)(6) 2011. No known surgical interventions have occurred to date. Attempts for additional relevant information have been unsuccessful to date.

 
Event Description

Additional information was received from the physician¿s office that the patient experienced painful stimulation on the left side of the face, neck and chest abruptly on (b)(6) 2014. The patient was seen post- surgery by the physician on (b)(6) 2014 and that the incision sites were reported to be healing well. Attempts were made for product information but were unsuccessful.

 
Manufacturer Narrative

Review of the available programming and diagnostic history. Device failure is suspected, but did not cause or contribute to a death or serious injury.

 
Manufacturer Narrative

Adverse event and/or product problem; additional information indicates that the event was not a product problem but an adverse event. Type of reportable event; additional information indicates that the event type was not a malfunction but a serious injury.

 
Event Description

Additional information was received stating that the vns patient underwent generator and lead replacement surgery on (b)(6) 2014. The explanting facility will not return explanted devices to the manufacturer for analysis and discard explants after 30 days; therefore, no analysis can be performed. Clinic notes were received indicating that the patient's device was tested during an office visit on (b)(6) 2014 and diagnostics showed lead impedance within normal limits (impedance value - 3000 ohms). After disabling the patient's device, the er physician prescribed medication for the patient. The notes indicate that the patient's painful stimulation occurred abruptly at her until the device was disabled and subsequently began having breakthrough seizures. A lead issue was suspected because of the patient's painful stimulation and not based on diagnostic results or x-rays. Operative notes for the patient's replacement surgery indicate that there was a significant amount of scarring around the nerve which required an external neurolysis as well as neurorrhaphy to prepare the nerve for placement of the new lead. The notes indicate that following placement of the new devices, the device was programmed on and showed low impedance. It is unclear whether the notes were referring to a low impedance reading or a low numerical impedance value that was within normal limits.

 
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Brand NameLEAD MODEL UNKNOWN
Type of DeviceLEAD
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 Key4171248
Report Number1644487-2014-02687
Device Sequence Number1
Product CodeLYJ
Report Source Manufacturer
Source Type Health Professional,Company Representative
Reporter Occupation HEALTH PROFESSIONAL
Type of Report Initial,Followup,Followup
Report Date 09/19/2014
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received10/14/2014
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? Yes
Device Operator LAY USER/PATIENT
Was Device Available For Evaluation? No
Is The Reporter A Health Professional? Yes
Event Location Other
Date Manufacturer Received12/03/2014
Was Device Evaluated By Manufacturer? Device Not Returned To Manufacturer
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: 10/14/2014 Patient Sequence Number: 1
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