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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 08/25/2006
Event Type  Injury  
Event Description

Reporter indicated that during a patient's vns generator replacement surgery due to end of service on (b)(6) 2006, it was noted by the surgeon that the lowest lead connection was off of the nerve, which was putting traction on the nerve. Releasing the tension moved the nerve back to a more normal position. The surgeon described the patient's tissue as "weakened", and that the tissues might be consistent with an underlying collagen vascular disorder. The patient's "tissue", specifically the fascia and collagenous tissues were described as weakened and lacking the usual texture that these tissues should demonstrate and it is suspected the patient has an underlying collagen vascular disorder. It is unclear if the possible collagen disorder caused the lead to migrate. No trauma occurred. The patient was also reported as experiencing neck pain at the time along with the lead migration.

 
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Brand NameLEAD MODEL 302
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
nydia herzog
100 cyberonics blvd
suite 600
houston , TX 77058
2812287200
MDR Report Key3023975
Report Number1644487-2013-00840
Device Sequence Number1
Product CodeLYJ
Report Source Manufacturer
Source Type Health Professional,Company Representative
Reporter Occupation
Type of Report Initial
Report Date 03/01/2013
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received03/27/2013
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? No
Device Operator LAY USER/PATIENT
Device EXPIRATION Date06/30/2006
Device MODEL Number302-20
Device LOT Number010763
Was Device Available For Evaluation? No
Is The Reporter A Health Professional? Yes
Event Location Other
Date Manufacturer Received03/01/2013
Was Device Evaluated By Manufacturer? Device Not Returned To Manufacturer
Date Device Manufactured06/23/2004
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: 03/27/2013 Patient Sequence Number: 1
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