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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: CYBERONICS, INC. PULSE GEN MODEL 105 GENERATOR

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CYBERONICS, INC. PULSE GEN MODEL 105 GENERATOR Back to Search Results
Model Number 105
Event Date 01/29/2015
Event Type  Injury  
Event Description

It was reported that the patient underwent initial vns implant and that on the way home from the surgery the patient scratched at the generator incision so much that the incision opened and the generator was pulled out along with several inches of lead body. The patient was taken back to the hospital where generator and lead (including electrodes) explant occurred. It was reported that the explanting facility plans to keep the explanted products for investigation and that product return may not occur for some time. It was reported that the plan is to let the patient heal and consider reimplant at a later date.

 
Manufacturer Narrative

 
Manufacturer Narrative

Suspect device udi: (b)(4). Additional manufacturer narrative and/or corrected data: suspect device udi was inadvertently left out of the initial mdr.

 
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Brand NamePULSE GEN MODEL 105
Type of DeviceGENERATOR
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 Key4535664
Report Number1644487-2015-03939
Device Sequence Number1
Product CodeLYJ
Report Source Manufacturer
Source Type Health Professional,Company Representative
Reporter Occupation
Type of Report Initial,Followup
Report Date 01/25/2015
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received02/23/2015
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? No
Device Operator LAY USER/PATIENT
Device EXPIRATION Date11/04/2016
Device MODEL Number105
Device LOT Number203183
Was Device Available For Evaluation? No
Is The Reporter A Health Professional? Yes
Event Location Other
Date Manufacturer Received04/13/2015
Was Device Evaluated By Manufacturer? Device Not Returned To Manufacturer
Date Device Manufactured12/05/2014
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: 02/23/2015 Patient Sequence Number: 1
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