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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: CYBERONICS, INC. LEAD MODEL 304

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CYBERONICS, INC. LEAD MODEL 304 Back to Search Results
Model Number 304-20
Event Date 12/15/2012
Event Type  Injury  
Event Description

Additional information was received through the investigation of the patient's generator explant due to inflammatory tissue and obvious wound opening (reported in manufacturer report number: 1644487-2013-00401), that the patient's lead was removed. It was stated that there lead was removed on (b)(6) 2013 from the patient due to a break in the sutures on the neck and direct exposure of the lead. The physician confirmed that the explant was due to the extruded wires as well as the inflammatory tissue which was related to the previously reported events in manufacturer report number: 1644487-2013-00401. No patient manipulation or trauma caused or contributed to the exposure of the lead. Attempts have been made for the return of the explanted lead for product analysis; however, the lead has not yet been returned. No additional information has been provided.

 
Event Description

The explanted lead was returned to the manufacturer on (b)(6) 2013 and product analysis was performed. Two sets of setscrew marks were seen on the connector pin, providing evidence that proper contact between the setscrew and the lead pin existed at least once. Also, the connector ring has scratches most likely caused by the canted spring in the pulse generator header during insertion of the lead connector. Scratches most likely caused during manipulation of the lead by the user were noted on the connector ring. Abrasions were identified on the connector boot and on the outer silicone tubing at multiple locations. The cut at the outer silicone tubing 17. 5 cm from the boot reached the inner silicone tubing of the lead coils, creating an opening. No obvious damage to the lead coils was noted at this location. The lead assembly has remnants of what appears to be dry body fluids inside the inner and the outer silicone tubing. No obvious point of entrance was noted other than the identified tubing opening and the end of the returned lead portion. Based on the appearance of the analyzed lead portion, it is believed that the identified punctures, kinks, superficial cuts, etc. Were most likely caused during the explant procedure. Scanning electron microscopy images of the positive coil show that the coil was torn (most likely due to rotational forces). Scanning electron microscopy images of the negative coil show that the coil was torn at the electrode as indicated by the presence of the weld slug still attached to the end of the coil. Also, secondary fractures identified in two of the coil strands in the vicinity of the weld suggest that this condition was most likely result of the explant procedure. Note that since the electrodes were not returned for analysis, an evaluation and resulting commentary cannot be made on that portion of the lead. Other than the above mentioned observations, typical wear, and explant related observations, no other anomalies were identified in the analyzed portions of the lead. No other information has been provided.

 
Event Description

Additional information had been received that the patient was re-implanted.

 
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Brand NameLEAD MODEL 304
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 Key3075114
Report Number1644487-2013-01144
Device Sequence Number1
Product CodeLYJ
Report Source Manufacturer
Source Type Health Professional,User facility,Company Representative
Reporter Occupation
Type of Report Initial,Followup,Followup
Report Date 03/25/2013
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received04/24/2013
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? No
Device Operator LAY USER/PATIENT
Device EXPIRATION Date07/31/2016
Device MODEL Number304-20
Device LOT Number3371
Was Device Available For Evaluation? Device Returned To Manufacturer
Date Returned to Manufacturer04/24/2013
Is The Reporter A Health Professional? Yes
Event Location Other
Date Manufacturer Received04/16/2014
Was Device Evaluated By Manufacturer? Yes
Date Device Manufactured07/13/2012
Is The Device Single Use? Yes
Is this a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial

Patient TREATMENT DATA
Date Received: 04/24/2013 Patient Sequence Number: 1
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