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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: CYBERONICS, INC. LEAD MODEL 303

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CYBERONICS, INC. LEAD MODEL 303 Back to Search Results
Model Number 303-20
Event Date 04/14/2014
Event Type  Injury  
Event Description

It was reported that the vns patient had an open wound at his neck incision site. Granulation tissue was observed eight months after implant and the open wound was first observed on (b)(6) 2014. The surgeon stated that there was no obvious reason for the granulation tissue. Debridement of the granulation tissue was performed. The surgeon stated that trauma possibly had caused or contributed to the event as the patient had seizures and hit the affected areas. No causal or contributor medication changes preceded the onset of the event. Further follow-up revealed that the patient was given antibiotics and the patient¿s issues resolved. The patient¿s issues came back and the surgeon stated that the device needed to be explanted due to abscesses at the lead site. No known surgical interventions have occurred to date.

 
Event Description

On (b)(6) 2014 product analysis was completed on the explanted generator. Results of diagnostic testing indicated that the battery status indicated ifi=no in the pa lab. The battery voltage was 2. 995 volts (not at ifi), as measured during completion of the final electrical test. 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. Product analysis on the lead was completed on (b)(6) 2014. Other than the typical wear and explant related observations, no anomalies were identified in the returned lead.

 
Manufacturer Narrative

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

 
Event Description

Additional information was received stating that the vns patient developed another pustule at his neck incision site. The surgeon previously packed the wound and the granulation tissue appeared to resolve by (b)(6) 2014. However, granulation tissue was noted at the same site during an office visit on (b)(6) 2014. The surgeon speculated that an infection had developed or the patient¿s body was rejecting the device. Cultures showed moderate staph. The patient underwent surgery on (b)(6) 2014 to explant his generator and lead. The explanted generator and lead have been returned to the manufacturer where analysis is currently underway.

 
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Brand NameLEAD MODEL 303
Type of DeviceLEAD
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 Key3864292
Report Number1644487-2014-01461
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 05/15/2014
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received06/10/2014
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? No
Device Operator LAY USER/PATIENT
Device EXPIRATION Date02/28/2017
Device MODEL Number303-20
Device LOT Number202391
Was Device Available For Evaluation? Device Returned To Manufacturer
Date Returned to Manufacturer06/24/2014
Is The Reporter A Health Professional? No
Event Location Other
Date Manufacturer Received08/29/2014
Was Device Evaluated By Manufacturer? Yes
Date Device Manufactured02/04/2013
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: 06/10/2014 Patient Sequence Number: 1
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