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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: CYBERONICS, INC. PULSE GEN MODEL 103 GENERATOR

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CYBERONICS, INC. PULSE GEN MODEL 103 GENERATOR Back to Search Results
Model Number 103
Event Date 04/26/2013
Event Type  Injury  
Event Description

It was reported that the vns patient was explanted on (b)(6) 2013 due to an infection. Cultures were taken which were positive for (b)(6). It was reported that the generator and only a portion of the lead were explanted. The electrodes were left on the nerve and the lead was cut at approximately clavicle level. Attempts to obtain additional info have been unsuccessful to date.

 
Manufacturer Narrative

Device manufacturing records were reviewed. Review of manufacturing records confirmed sterilization for both the generator and lead prior to distribution.

 
Event Description

Further follow-up revealed that the infection was first observed on (b)(6) 2013. The physician indicated that the patient¿s caregivers kept picking up the patient by the armpits which did not allow the incision to heal properly and the wound dehisced. The infection was at the left chest incision.

 
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Brand NamePULSE GEN MODEL 103
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
nydia herzog
100 cyberonics blvd
suite 600
houston , TX 77058
2812287200
MDR Report Key3129631
Report Number1644487-2013-01577
Device Sequence Number1
Product CodeLYJ
Report Source Manufacturer
Source Type Health Professional,Company Representative
Reporter Occupation
Type of Report Initial,Followup
Report Date 05/01/2013
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received05/24/2013
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? No
Device Operator LAY USER/PATIENT
Device EXPIRATION Date08/31/2014
Device MODEL Number103
Device LOT Number3431
Was Device Available For Evaluation? No
Is The Reporter A Health Professional? Yes
Event Location Other
Date Manufacturer Received05/24/2013
Was Device Evaluated By Manufacturer? Device Not Returned To Manufacturer
Date Device Manufactured09/26/2012
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: 05/24/2013 Patient Sequence Number: 1
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