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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: CYBERONICS, INC. BIPOL LEAD MODEL 300

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CYBERONICS, INC. BIPOL LEAD MODEL 300 Back to Search Results
Model Number 300-20
Device Problem Patient-Device Incompatibility
Event Date 08/14/2013
Event Type  Injury  
Event Description

It was reported that the patient was seen due to a lump at the electrode site that was sensitive, but not painful. There was no fever or pus, but the surgeon ordered x-rays and ct scans to determine what the issue may be. The patient was scheduled for surgery to lance the lump. The surgeon was not sure what the issue was and the cause was unclear as the patient has been implanted for some time. Additional information was received on (b)(6) 2013, during the exploratory surgery. The physician was able to perform interrogation and run diagnostics, which showed the device was within normal limits, during surgery. Per the surgeon, there was a lump of fibrous tissue around the electrodes, which he referred to as a "taboma". The surgeon indicated that he removed the tissue and performed interrogation and diagnostics again. The surgeon noticed that the outer tubing of the lead was cracked; however, the inner tubing was fine. He stated that he would not be performing a lead revision. Review of the lead device history records confirmed all quality tests were passed prior to distribution after being reworked. Follow up with the physician found that the fibrous tissue was likely related to a foreign body response. The notes indicate that there were fibrous, acute and chronic inflammation of focal giant cell reaction. The initial prognosis was "painful mass in the neck around the lead" so the surgery was taken due to the pain. Pain was not related to stimulation. The site did not indicate if the surgery was to preclude a serious injury or not. The patient's outcome is good, and there was no external trauma or manipulation of the electrode area that is believed to have caused the pain/lump. No additional information was provided.

 
Event Description

Additional information was received indicating that the cause of the left neck scarring was continued fibrosis that was observed previously in this patient. The deformed/dimpled neck scar was removed during the attempted generator repositioning surgery as part of a lead removal procedure. It was indicated that the intervention was for patient comfort and cosmetics and not to preclude a serious injury. The attempted generator repositioning surgery is reported in mfr. Report #1644487-2015-05251.

 
Event Description

Additional information was received stating that the patient had a neck scar that was deformed and dimpled without any active inflammation in his neck incision the patient's mother asked the surgeon to revise the neck scar during a planned generator repositioning surgery. The repositioning surgery was attempted but it is unknown if the neck scar was revised. Attempts for additional relevant information have been unsuccessful to date.

 
Event Description

The explanting facility indicated that the explanted generator and lead portion were discarded and are therefore unable to be returned for product analysis.

 
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Brand NameBIPOL LEAD MODEL 300
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 Key3344698
Report Number1644487-2013-02671
Device Sequence Number1
Product CodeLYJ
Report Source Manufacturer
Source Type Health Professional,Company Representative,COMPANY REPRESENTATIVE
Reporter Occupation
Type of Report Initial,Followup,Followup,Followup
Report Date 08/14/2013
1 Device Was Involved in the Event
0 PatientS WERE Involved in the Event:
Date FDA Received09/12/2013
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? No
Device Operator LAY USER/PATIENT
Device EXPIRATION Date07/31/2003
Device MODEL Number300-20
Device LOT Number3714
Was Device Available For Evaluation? No
Is The Reporter A Health Professional? No
Was the Report Sent to FDA?
Event Location Other
Date Manufacturer Received08/06/2015
Was Device Evaluated By Manufacturer? Device Not Returned To Manufacturer
Date Device Manufactured07/28/2001
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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