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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 Problems Detachment Of Device Component; Appropriate Term/Code Not Available
Event Date 12/12/2017
Event Type  Malfunction  
Event Description

During a patient's prophylactic, full revision surgery, the positive and anchor electrodes were found to be detached from the vagus nerve and covered in scar tissue. Also, inadequate strain relief was found to have been provided by the original implanting surgeon. System diagnostics were performed before the revision surgery and indicated the device was functioning normally. Also, the patient's neurologist stated that no physical trauma or manipulation had occurred that may have caused the detachment. The lead has been returned and analysis is underway. No additional or relevant information has been received to date.

 
Event Description

Product analysis for the returned lead has been completed. Inspection of the electrode array found that no suture was present at the anchor tether, and the presence of a lengthwise cavity along the helix's inner surface indicating the suture was present at one time. The positive and negative coils were found to be kinked, and a partial tear was found on the positive electrode. The closest electrode to the bifurcation is damaged showing bends on the electrode ribbon and a partial tear. The absence of suture at the anchor tether and the general condition of the electrode array (anchor tether, closest, and furthest electrode to the bifurcation) was most likely manipulation of electrode array not consistent with our labeling at implant/explant. Also, the lead electrodes including the anchor tether were installed in a training fixture with no anomalies identified that would prevent placement of the electrodes or anchor tether. Based on the appearance of the returned lead portions, it is believed that the identified kinks were most likely caused during the explant procedure. Other than the above mentioned observations and typical wear and explant related observations, no product-related anomalies were identified in the returned lead portions.

 
Event Description

A review of device history records for the lead shows that no unresolved non-conformances were found.

 
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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 Key7168033
Report Number1644487-2018-00011
Device Sequence Number1
Product CodeLYJ
Report Source Manufacturer
Source Type COMPANY REPRESENTATIVE,HEALTH
Reporter Occupation
Type of Report Initial
Report Date 02/28/2018
1 Device Was Involved in the Event
0 PatientS WERE Involved in the Event:
Date FDA Received01/05/2018
Is This An Adverse Event Report? No
Is This A Product Problem Report? Yes
Device Operator LAY USER/PATIENT
Device EXPIRATION Date03/31/2002
Device MODEL Number300-20
Device LOT Number35919C
Was Device Available For Evaluation? Device Returned To Manufacturer
Date Returned to Manufacturer12/20/2017
Is The Reporter A Health Professional? Yes
Was the Report Sent to FDA?
Event Location Other
Date Manufacturer Received02/28/2018
Was Device Evaluated By Manufacturer? Yes
Date Device Manufactured02/08/2000
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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