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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: CYBERONICS, INC. PULSE GEN MODEL 102 GENERATOR

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CYBERONICS, INC. PULSE GEN MODEL 102 GENERATOR Back to Search Results
Model Number 102
Event Date 09/06/2013
Event Type  Injury  
Event Description

It was reported that the patient underwent surgery to reposition the generator because the generator was coming out of the incision. The surgeon reported that the generator had just been placed and that the pocket was not big enough and this was the reason the generator was coming out of the incision. The surgeon deepened the pocket and repositioned the generator. The surgeon indicated that device diagnostics were within normal limits following the surgery. Attempts to obtain additional information have been unsuccessful to date.

 
Event Description

Product information was obtained.

 
Manufacturer Narrative

Serial #, lot #, expiration date, corrected data: previously submitted mdr indicated this information was unknown. It is now known. This report is being submitted to correct this data. Manufacture date, corrected data: previously submitted mdr indicated this information was unknown. It is now known. This report is being submitted to correct this data.

 
Manufacturer Narrative

Brand name, corrected data: follow-up showed that the suspect medical device was a model 102 generator. This information was inadvertently omitted from supplemental report 01. Attempts for the device serial number have been unsuccessful. Model, corrected data: follow-up showed that the suspect medical device was a model 102 generator. This information was inadvertently omitted from supplemental report 01. Attempts for the device serial number have been unsuccessful.

 
Event Description

Follow up with the physician found that there was no trauma or manipulation. No infection found after cultures were taken. Parents called because they believed they could see an opening at the generator site. The physician reported that the generator may need to be to deeper location in the left chest. Wound dehiscence performed on (b)(6) 2013. Patient's device was repositioned on the (b)(6) 2013. No causal or contributory medication or diet changes (affecting wound healing) preceded the onset of the event. It was clarified that the device was repositioned in surgery, and not replaced.

 
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Brand NamePULSE GEN MODEL 102
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 Key3388554
Report Number1644487-2013-03037
Device Sequence Number1
Product CodeLYJ
Report Source Manufacturer
Source Type Health Professional,Company Representative
Reporter Occupation
Type of Report Initial,Followup,Followup,Followup
Report Date 09/06/2013
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received10/04/2013
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? No
Device Operator LAY USER/PATIENT
Device EXPIRATION Date02/28/2015
Device MODEL Number102
Device LOT Number202460
Was Device Available For Evaluation? No
Is The Reporter A Health Professional? Yes
Event Location Other
Date Manufacturer Received07/09/2014
Was Device Evaluated By Manufacturer? Device Not Returned To Manufacturer
Date Device Manufactured03/19/2013
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: 10/04/2013 Patient Sequence Number: 1
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