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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 08/22/2011
Event Type  Malfunction  
Event Description

On (b)(6) 2012, a surgeon reported that he was performed a battery replacement. Prior to surgery there was no evidence of high impedance; however, after a new generator was connected, high impedance was seen. The surgeon stated that he removed the pin and then reinserted; however, a dcdc code of 7 was reported (the actual evidence of high impedance is unknown as the generator that was connected would provide an impedance value in ohms, not a dcdc code). The surgeon stated that there he was in the process of revising the lead. The physician phoned in a second time and reported that high impedance was seen after the lead was revised. The surgeon replaced the generator that had been implanted earlier in the surgery and reported that everything was okay. No additional information was provided regarding why the high impedance was attributed to the new generator. The high impedance on the generator is captured in mfr report #1644487-2012-01872. Follow up with the surgeon's office on (b)(6) 2012, revealed that no additional information was available; however, operative notes would be provided. Pre-operative diagnoses indicated there was a malfunction of the neurologic device. Postoperative diagnoses also indicated a malfunction of the neurologic device. Operative findings indicated high lead impedance, fracture of the rostral most electrode, and a defective model 103 generator. The patient's settings were provided. It was stated that as the battery had reported a near end of life message, the patient opted for revision. During the procedure, electrocautery was used to reach the generator. The generator was removed and a new generator (m103) was connected. High lead impedance was seen. The old generator was reattached and high impedance was seen again, reportedly consistent with an electrode malfunction. The incision at the neck was reopened, and the electrode wire was found to be fractured at two points: after the level of bifurcation of the electrode wire into two single wires and the wires. The wire was reportedly heavily scarred in. The electrode coils were removed, and a new electrode was placed. The new generator was attached to the new electrode, and high lead impedance was seen again. The notes stated that, at this point, the patient was clear with all scar tissue having been resected; therefore, "the problem at this point laid in the generator". A second new generator was programmed to the patient's pre-implant settings and replaced in the anterior chest wall pocket. The electrode distal to the electrode coils was secured was plastic pledgets and 3-0 silk suture. Care was taken to maintain a generous strain relief loop and to avoid any tension or kinks in the electrode within the neck. Attempts for product return have been unsuccessful as the facility only releases explanted devices to patients. Attempts for product information have been unsuccessful.

 
Event Description

During the periodic programming history review, it was noted that high impedance was observed on (b)(6) 2011. No further diagnostics are available. Follow up with the physician confirmed that the replacement surgery which occurred on (b)(6) 2012 was for high impedance. The physician could not recall if the vns device was disabled to 0ma after the high lead impedance was observed and was uncertain if x-rays were taken as the "patient ran away for almost one year. " there was no manipulation or trauma that occurred which is believed to have caused or contributed to the lead fracture.

 
Manufacturer Narrative

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

 
Manufacturer Narrative

Corrected data: additional information was received which indicates the date reported on the initial mdr was incorrect. Analysis of programming history.

 
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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 Key2669008
Report Number1644487-2012-01871
Device Sequence Number1
Product CodeLYJ
Report Source Manufacturer
Source Type Health Professional,Company Representative
Reporter Occupation
Type of Report Initial,Followup
Report Date 06/26/2012
1 Device Was Involved in the Event
0 PatientS WERE Involved in the Event:
Date FDA Received07/25/2012
Is This An Adverse Event Report? No
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 Received09/09/2013
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

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