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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 04/14/2011
Event Type  Injury  
Event Description

It was initially reported that the patient surgical incision opened up after a generator and lead replacement. The patient had picked at the incision and opened up the scab and picked off all the overlying glue. The incision had begun bleeding. The patient reported that the incision had itched. The bottom of the chest incision was exposed but the subcutaneous stitches were still intact. There was no erythema at the incision site but there was some drainage. The neck incision was clean, dry and intact. The exposed incision was cleaned with hydrogen peroxide and then dermabond was used to reapproximate the skin edges. Once the dermabond was dried a dressing was placed over the incision and then layered with paper tape. The neck incision was also covered to prevent that site from being scratched.

 
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Brand NamePULSE GEN MODEL 103
Type of DeviceGENERATOR
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 Key3066120
Report Number1644487-2013-01061
Device Sequence Number1
Product CodeLYJ
Report Source Manufacturer
Source Type Health Professional,Company Representative
Reporter Occupation PHYSICIAN ASSISTANT
Type of Report Initial
Report Date 03/20/2013
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received04/18/2013
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? No
Device Operator LAY USER/PATIENT
Device EXPIRATION Date11/30/2012
Device MODEL Number103
Device LOT Number2862
Was Device Available For Evaluation? No
Is The Reporter A Health Professional? Yes
Event Location Other
Date Manufacturer Received03/20/2013
Was Device Evaluated By Manufacturer? Device Not Returned To Manufacturer
Date Device Manufactured11/30/2010
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: 04/18/2013 Patient Sequence Number: 1
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