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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
Event Date 03/31/2014
Event Type  Malfunction  
Event Description

Further information was later received indicating that high impedance had been found on (b)(6) 2014 with a generator that was replaced on (b)(6) 2014. During battery replacement surgery, the old generator was removed and when the new generator was connected to the existing lead, system diagnostics were run which returned high impedance. The leads were cleaned and the test was repeated multiple times, with persisting high impedance results. Generator diagnostics were run with the new generator which returned normal impedance. The generator replacement was completed leaving the existing lead implanted. Programming history was reviewed, which confirmed that the pulse generator was disabled on (b)(6) 2014. Further information was received indicating that it was believed that the surgeon cleaned and reconnected the lead and the high impedance condition reportedly resolved. Review of the available programming and diagnostic history showed that the patient's device was tested on (b)(6) 2014 and system diagnostic results showed high impedance. A system diagnostic test was performed later the same day and showed lead impedance within normal limits. No other known surgical interventions have occurred to date.

 
Manufacturer Narrative

Device manufacturing records and available programming and diagnostic history were reviewed. Review of manufacturing records confirmed that the lead passed all functional tests prior to distribution. Brand name; corrected data: the previously submitted mdr inadvertently provided the wrong suspect device for the event. Type of device, name; corrected data: the previously submitted mdr inadvertently provided the wrong suspect device for the event. Model #, serial #, lot#, expiration date; corrected data: the previously submitted mdr inadvertently provided the wrong suspect device for the event. Operator of device; corrected data: the previously submitted mdr inadvertently provided the wrong device operator for the event. Date of implant; corrected data: the previously submitted mdr inadvertently provided the wrong suspect device for the event. Device manufacture date; corrected data: the previously submitted mdr inadvertently provided the wrong suspect device for the event. Labeled for single use; corrected data: the previously submitted mdr inadvertently provided the wrong suspect device for the event. Usage of device; corrected data: the previously submitted mdr inadvertently provided the wrong suspect device for the event.

 
Event Description

During review of the in-house programming/diagnostic history database, it was observed that high impedance was observed at office visit on (b)(6) 2014. It is unknown if any patient manipulation or trauma occurred that could have caused or contributed to the high impedance reading. It is unknown if surgery has been performed. Attempts to obtain additional information have been unsuccessful to date.

 
Manufacturer Narrative

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

 
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Brand NameLEAD MODEL 302
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 Key4553968
Report Number1644487-2015-03999
Device Sequence Number1
Product CodeLYJ
Report Source Manufacturer
Source Type Foreign,Health Professional,Company Representative
Reporter Occupation
Type of Report Initial,Followup
Report Date 01/28/2015
1 Device Was Involved in the Event
0 PatientS WERE Involved in the Event:
Date FDA Received02/27/2015
Is This An Adverse Event Report? No
Is This A Product Problem Report? Yes
Device Operator LAY USER/PATIENT
Device EXPIRATION Date01/31/2011
Device MODEL Number302-20
Device LOT Number200701
Was Device Available For Evaluation? No
Is The Reporter A Health Professional? No
Event Location Other
Date Manufacturer Received03/04/2015
Was Device Evaluated By Manufacturer? Device Not Returned To Manufacturer
Date Device Manufactured01/01/2008
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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