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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: CYBERONICS, INC. PULSE GEN MODEL 104 GENERATOR

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CYBERONICS, INC. PULSE GEN MODEL 104 GENERATOR Back to Search Results
Model Number 104
Event Date 05/30/2012
Event Type  Injury  
Event Description

Additional information was received indicating the patient has been reimplanted with a new vns lead and generator.

 
Manufacturer Narrative

Type of report, corrected data: initial report inadvertently did not indicate "30-day".

 
Manufacturer Narrative

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

 
Event Description

It was reported that the patient's vns had been previously explanted due to an infection and now wanted to be re-implanted. The patient's mother indicated that the patient picks at the wound site. Follow-up with the physician's office found that drainage was noted at the wound site on (b)(6) 2010. The patient underwent debridement on (b)(6) 2010. The next note indicated that blood blisters were observed around the generator site per the patient's mother on (b)(6) 2011. The patient was then seen in the clinic on (b)(6) 2011 and the patient was taken to the or on (b)(6) 2011 for irrigation and re-suturing of the generator pocket. A note dated (b)(6) 2011 indicated that the patient pulled out 7 of his stitches. The generator was explanted on (b)(6) 2011 due to "multiple infections. " a later note dated (b)(6) 2011 indicated left wound revision "with plastics. " cultures taken on that date indicated (b)(6). The patient's parent elected to not have the lead removed at that time. A note dated (b)(6) 2011 indicated "infection with dehiscence evident. " the entire lead was removed on (b)(6) 2011. Cultures taken on that date indicated (b)(6). Antibiotics were used throughout the treatment of the infection.

 
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Brand NamePULSE GEN MODEL 104
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 Key2618817
Report Number1644487-2012-01523
Device Sequence Number1
Product CodeLYJ
Report Source Manufacturer
Source Type Health Professional,Company Representative
Reporter Occupation
Type of Report Initial,Followup
Report Date 05/18/2012
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received06/17/2012
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? No
Device Operator LAY USER/PATIENT
Device EXPIRATION Date04/30/2012
Device MODEL Number104
Device LOT Number2694
Was Device Available For Evaluation? No
Is The Reporter A Health Professional? Yes
Event Location Other
Date Manufacturer Received07/31/2012
Was Device Evaluated By Manufacturer? Device Not Returned To Manufacturer
Date Device Manufactured06/04/2010
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: 06/17/2012 Patient Sequence Number: 1
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