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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: CYBERONICS, INC. LEAD MODEL 302

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CYBERONICS, INC. LEAD MODEL 302 Back to Search Results
Model Number 302-20
Device Problems Detachment Of Device Component; High impedance
Event Date 07/17/2015
Event Type  Malfunction  
Event Description

Clinic notes were received and indicated that the patient had experienced pain associated with stimulation. There was also a report of a settings adjustment which helped with the pain. The patient then underwent a prophylactic generator replacement surgery on (b)(6) 2015. However, pre-operative system diagnostics resulted in high impedance detected on the patient's vns system. Thus, the lead was replaced as well. It was reported that during the lead replacement, it was seen that the positive electrode and anchor tether of the lead had become detached from the patient's vagus nerve, leaving only the negative helical electrode still attached. No lead fractures were noted. It was unknown how the lead had become partially detached form the nerve. The diagnostics were normal following the generator and lead replacement. The explanted generator and lead were received by the manufacturer for analysis. However, analysis has not been completed to date.

 
Manufacturer Narrative

Describe event or problem; corrected data: the previously submitted mdr inadvertently failed to report the device evaluation.

 
Event Description

Analysis was completed on the patient's explanted generator. Analysis showed that the generator performed according to functional specifications. Analysis of the generator concluded that no abnormal performance or any other type of adverse condition was found. An analysis was performed on the returned lead portion. Note that a portion of the lead assembly including the electrodes was not returned for analysis and therefore a complete evaluation could not be performed on the entire lead product. No obvious anomalies were noted. The setscrew marks found on the lead connector pin provide evidence that, at one point in time, a good mechanical and electrical connection was present. Continuity checks of the returned lead portion were performed, during the visual analysis, and no discontinuities were identified.

 
Event Description

Additional information was received that the patient's pain had been occurring in the patient's neck prior to the generator and lead replacement surgery. The pain began occurring following a settings increase. Thus, the settings were decreased which helped the pain. The pain was thought to perhaps have been caused by the detached electrode. No additional relevant information has been obtained to date.

 
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Brand NameLEAD MODEL 302
Type of DeviceLEAD
Manufacturer (Section D)
CYBERONICS, INC.
100 cyberonics blvd
houston TX 77058
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 Key5002392
Report Number1644487-2015-05462
Device Sequence Number1
Product CodeLYJ
Report Source Manufacturer
Reporter Occupation HEALTH PROFESSIONAL
Type of Report Followup,Followup
Report Date 07/17/2015
1 Device Was Involved in the Event
0 PatientS WERE Involved in the Event:
Date FDA Received08/13/2015
Is This An Adverse Event Report? No
Is This A Product Problem Report? Yes
Device Operator LAY USER/PATIENT
Device EXPIRATION Date04/30/2008
Device MODEL Number302-20
Device LOT Number1022
Was Device Available For Evaluation? Device Returned To Manufacturer
Date Returned to Manufacturer07/29/2015
Is The Reporter A Health Professional? Yes
Was the Report Sent to FDA?
Event Location Other
Date Manufacturer Received09/11/2015
Was Device Evaluated By Manufacturer? Yes
Date Device Manufactured04/07/2005
Is The Device Single Use? Yes
Is this a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial

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