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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: CYBERONICS, INC. LEAD MODEL 302

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CYBERONICS, INC. LEAD MODEL 302 Back to Search Results
Model Number 302-20
Event Date 05/09/2011
Event Type  Injury  
Event Description

It was initially reported by the epileptologist that the patient was to undergo a prophylactic generator replacement, and at the same time have his lead released from scar tissue. Additional information was received through an implant card indicating that the patient's lead was replaced and the patient had been experiencing coughing, tightness in the lead, and difficulty breathing. A review of the patient's history showed that the patient was implanted in 2006. The patient had started experiencing pain and tightness in his neck, following implant. This resulted in a procedure to release his lead wire from scar tissue in (b)(6) 2009. At that time, the procedure was performed for patient comfort. Follow up with the surgeon revealed that the patient's pain and tightness had reoccurred approximately a year after the previous surgery. The symptoms had gradually worsened, until it caused the patient pain and coughing when he turned his head to the right. During the procedure to loosen the lead wire from the scar tissue, the surgeon noticed damage to the "lead sheath" so he replace the lead wire. He indicated that the patient had developed severe fibrosis which entrapped the cable causing the pain, coughing, and discomfort. The fibrosis was also restricting the patient's neck motion. The surgeon stated that the procedure was performed primarily for patient comfort, but also potentially to preclude a serious injury. Follow up for additional information regarding the damage to the lead has been unsuccessful to date. The explanted products have not been returned to the manufacturer for product analysis.

 
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Brand NameLEAD MODEL 302
Manufacturer (Section D)
CYBERONICS, INC.
houston TX 77058
Manufacturer Contact
nydia grimes
100 cyberonics blvd.
ste. 600
houston , TX 77058
2812287200
MDR Report Key2129926
Report Number1644487-2011-01264
Device Sequence Number1
Product CodeLYJ
Report Source Manufacturer
Source Type Health Professional,Company Representative
Reporter Occupation
Type of Report Initial
Report Date 05/09/2011
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received06/07/2011
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? Yes
Device Operator LAY USER/PATIENT
Device EXPIRATION Date03/31/2008
Device MODEL Number302-20
Device LOT Number1012
Was Device Available For Evaluation? No
Is The Reporter A Health Professional? Yes
Date Manufacturer Received05/09/2011
Was Device Evaluated By Manufacturer? Device Not Returned To Manufacturer
Date Device Manufactured04/01/2005
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: 06/07/2011 Patient Sequence Number: 1
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