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U.S. Department of Health and Human Services

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

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CYBERONICS, INC. PULSE GEN MODEL 103 Back to Search Results
Model Number 103
Event Date 04/01/2013
Event Type  Injury  
Event Description

On (b)(4) 2013 product analysis was completed on the explanted generator. Results of diagnostic testing indicated the device was operating properly and communicated properly. Electrical test results showed that the pulse generator performed according to functional specifications. There were no adverse functional, mechanical, or visual issues identified with the returned generator.

 
Manufacturer Narrative

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

 
Event Description

There was no known relationship of their events to any patient manipulation or trauma. Unknown relationship to their vns device. The patient's explanted generator was returned for analysis and pending completion. Cultures were taken on (b)(6) 2013 from chest site. Few staphylococcus and rare staphylococcus species coagulase negative. It was reported that their pocket failed to heal.

 
Event Description

It was reported via clinic notes that a vns patient was having difficulties with their vns pocket. They had a battery replacement (b)(6) 2013 and at that time their vns pocket was revised. Their sutures were removed. She then experienced dehiscence of their more superior wound and generator migration of their generator to the surface. It was granulating. The patient was scheduled for , incision, drainage, debridement and closure of the left chest wound. The patient had a wound debridement and incision and drainage on (b)(6). The superior wound was debrided of granulation tissue. The inferior wound had a small soft area in the middle. It appeared that there was a connection subcutaneously between the two wounds with some fluid present. This was evacuated. A small area of atropic skin was inferiorly excised. Copious bacitracin irrigation was used prior to closure. The patient was seen for their postop visit on (b)(6) and their incision was intact. There was some serosanguinous drainage likely from removal of their granulated tissue. The patient was put on keflex prophylactically and was to be seen again on (b)(6) for followup and to decide next plan of care. The patient thought her skin incision looked thin and was concerned about opening. On (b)(6) the patient's generator was removed and it was decided to let their pocket heal prior to generator replacement.

 
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Brand NamePULSE GEN MODEL 103
Type of DevicePULSE GEN MODEL 103
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 Key3120397
Report Number1644487-2013-01211
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 04/25/2013
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received05/20/2013
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? No
Device Operator LAY USER/PATIENT
Device EXPIRATION Date09/30/2014
Device MODEL Number103
Device LOT Number202283
Was Device Available For Evaluation? Device Returned To Manufacturer
Date Returned to Manufacturer05/30/2013
Is The Reporter A Health Professional? Yes
Event Location Other
Date Manufacturer Received09/04/2013
Was Device Evaluated By Manufacturer? Yes
Date Device Manufactured10/16/2012
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: 05/20/2013 Patient Sequence Number: 1
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