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CYBERONICS INC LEAD MODEL 304 Back to Search Results
Model Number 304-20
Event Date 07/11/2013
Event Type  Malfunction  
Event Description

On (b)(6) 2013, an image of a patient¿s neck/chest area was provided where it appeared that the generator was sideways and protruding. Follow-up showed that the patient was implanted on (b)(6) 2013. The patient was seen on (b)(6) 2013 and reported that the device had been the way it was for a couple of weeks. Thee surgeon manipulated the device with some improvement of the protrusion. The patient was advised to continue to observe, but no intervention was recommended. There was no reported patient manipulation, trauma, or physiological changes that may have caused/contributed to the event. Follow-up with the surgeon showed that there was slight protrusion/flipping of the patient¿s generator. Clinic notes dated (b)(6) 2103 indicated that the patient had pain at the generator site when lying prone and on her side. The generator was mildly painful to palpitation. The device appeared rotated within the surgical pocket and was protruding beneath the skin. The device had not been programmed on. Clinic noted dated (b)(6) 2013 indicated that the patient returned for titration. The patient had continued pain at the generator site when lying prone or on her side. The device was interrogated: 0. 50/30/500/30/5/0. 75/60/500. The patient¿s pain would continue to be observed. Clinic notes dated (b)(6) 2013 indicated that the patient continued to have discomfort intermittently with stimulation, particularly when lying down at night. A system diagnostic was performed with results of 3282 ohms. The patient was unable to tolerate an increase in output current, so stimulation was returned to the previous settings. Device settings were provided: 0. 50/30/500/30/5/0. 75/60/500. A revision referral indicated that the patient was to be revised due to discomfort and slightly elevated lead impedance. Follow-up showed that the referral was for patient comfort. On (b)(6) 2013, the patient underwent lead revision. At the time of surgery, fluid was seen in the outer tubing. The generator was briefly soaking in betadine. It was also noted that the lead was placed on the wrong nerve (anysa) by the previous surgeon. The new surgeon fixed the issue and notified the neurologist. The implant card indicated that the replacement was due to an "adverse event" and "malfunction". No other information has been provided.

Manufacturer Narrative

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

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Brand NameLEAD MODEL 304
Type of DeviceLEAD
Manufacturer (Section D)
100 cyberonics blvd
houston TX 77058
Manufacturer (Section G)
100 cyberonics blvd
suite 600
houston TX 77058
Manufacturer Contact
njemile crawley
100 cyberonics blvd
suite 600
houston , TX 77058
MDR Report Key3444285
Report Number1644487-2013-03392
Device Sequence Number1
Product CodeLYJ
Report Source Manufacturer
Source Type Health Professional,Company Representative
Reporter Occupation
Type of Report Initial
Report Date 10/04/2013
1 Device Was Involved in the Event
0 PatientS WERE Involved in the Event:
Date FDA Received11/01/2013
Is This An Adverse Event Report? No
Is This A Product Problem Report? Yes
Device Operator LAY USER/PATIENT
Device EXPIRATION Date10/31/2016
Device MODEL Number304-20
Was Device Available For Evaluation? No
Is The Reporter A Health Professional? Yes
Event Location Other
Date Manufacturer Received10/04/2013
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