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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 302-30
Event Date 01/27/2014
Event Type  Malfunction  
Event Description

It was reported that the patient underwent generator replacement surgery due to battery depletion and that high impedance was observed after the generator was connected to the existing lead. The explanted generator was completely depleted; therefore, high impedance was not observed prior to replacement. The patient did not undergo lead replacement at that time. The patient underwent lead replacement on (b)(6) 2016. The explanted lead was discarded therefore, no product analysis can be performed.

 
Manufacturer Narrative

The initial report inadvertently did not report the information about the scar.

 
Event Description

It was reported that the surgeon could not remove much of the old lead due to normal scar tissue as result of the healing process. Upon follow-up with the company representative that attended the surgery, it was reported that the lead pin was confirmed to be fully inserted into the generator header. The header was checked and appears to be free of obstruction and fluid during the surgery. There did not appear to be any visible damage to the explanted lead. Generator diagnostics with the replacement device were within normal limits which ruled out a generator issue. The lead was not replaced on (b)(6) 2016 because the patient had not approved prior to surgery to replace the lead. It was mentioned the patient had vocal cord damage from a prior vns implant surgery, as reported previously in mfg report #: 1644487-2004-00831. At that time, it was clarified that the surgeon had accidently hit the jugular vein, as reported in mfg report #: 1644487-2004-00831. No additional relevant information has been received.

 
Event Description

The company representative reported that the patient indicated that she had "damage" from a previous vns surgery. This is what was referred to in the previous report as "vocal cord damage. " the damage was previously reported in mfg report #: 1644487-2004-00831.

 
Event Description

The explanted generator was received by the manufacturer. An end-of-service warning message was verified in the (b)(6) lab and found to be associated with the output being disabled by the pulse generator, due to the pulse generator remaining ¿on¿ post explant. In addition, review of the ram/flash data downloaded from the pulse generator shows an indication of pre-explant increased impedance; on approximately (b)(6) 2014, impedance had a 62;25% change of 7355 ohms to 9316 ohms, and the time of change detection (b)(6) 2014. No anomalies were identified with the performance of the generator and the device performed according to specifications.

 
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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 Key5817438
Report Number1644487-2016-01676
Device Sequence Number1
Product CodeLYJ
Report Source Manufacturer
Source Type CONSUMER
Reporter Occupation
Type of Report Followup,Followup,Followup
Report Date 07/07/2016
1 Device Was Involved in the Event
0 PatientS WERE Involved in the Event:
Date FDA Received07/22/2016
Is This An Adverse Event Report? No
Is This A Product Problem Report? Yes
Device Operator LAY USER/PATIENT
Device EXPIRATION Date08/31/2004
Device MODEL Number302-30
Device LOT Number6736
Was Device Available For Evaluation? No
Is The Reporter A Health Professional? Yes
Was the Report Sent to FDA?
Event Location Other
Date Manufacturer Received09/28/2016
Was Device Evaluated By Manufacturer? Device Not Returned To Manufacturer
Date Device Manufactured08/02/2002
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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