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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 01/22/2015
Event Type  Malfunction  
Event Description

It was reported that the vns patient¿s device showed high impedance (dcdc ¿ 4). The patient had been experiencing an increase in seizures. The patient was last seen in (b)(6) 2014 and no issues were noted at that time. X-rays were taken and were reported by the physician to be unremarkable. X-rays dated (b)(6) 2014 were provided to the manufacturer for further review. The generator appears in the left chest in a normal placement. The filter feed-through wires appear to be intact. The lead connector pin appears fully inserted into the generator connector block. Part of the lead was behind the generator and could not be assessed. No clear lead breaks or sharp angles were found in the parts of the lead that could be assessed. Follow-up revealed that the patient¿s device was tested again on (b)(6) 2015 and system diagnostic results showed lead impedance within normal limits. It was noted that the patient¿s device output current had been decreased from 2. 5ma to 1. 75ma so the issue may have been due to device settings. The patient was referred for surgery but no known surgical interventions have occurred to date.

 
Manufacturer Narrative

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

 
Event Description

X-rays that were provided to the manufacturer for review were not dated.

 
Manufacturer Narrative

Manufacturer reviewed x-rays of implanted device. Review of the available programming and diagnostic history. X-rays reviewed by manufacturer, no gross lead discontinuities visualized. Describe event or problem; corrected data: the previously submitted mdr inadvertently stated that the x-ray images were dated (b)(6) 2014. The images did not contain a date. Evaluation codes, methods, results; additional manufacturer narrative and/or corrected data; corrected data: the previously submitted mdr inadvertently did not provide this information based on the available information. Method and results should have been provided along with explanations.

 
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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 Key4524501
Report Number1644487-2015-03879
Device Sequence Number1
Product CodeLYJ
Report Source Manufacturer
Source Type Foreign,Health Professional,Company Representative
Reporter Occupation HEALTH PROFESSIONAL
Type of Report Initial,Followup
Report Date 01/22/2015
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received02/18/2015
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 Received03/02/2015
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: 02/18/2015 Patient Sequence Number: 1
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