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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 03/29/2013
Event Type  Injury  
Event Description

It was reported that the vns patient's device was hanging out of the wound. It was reported that the patient had recently underwent generator replacement surgery. The patient was referred to surgeon. It was later reported that the patient had an infection that started at the lead site after the patient picked open the incision from generator replacement. It was reported that the patient picking at the incision has caused the generator to extrude. It was reported that the patient had a pustule that traveled up the lead. There appears to be a boil-looking abscess at the neck site. The patient underwent generator explant on (b)(6) 2013 due to the extrusion and infection. The lead was left in place and the surgeon debrided the chest wall and neck and performed cultures. The cultures found (b)(6) at time of explant. The surgeon indicated that the wound will be left open for a few days and will be packed with antibiotic dressing and the patient will be treated with oral antibiotics. A second set of cultures were obtained on (b)(6) 2013 which were negative. It was reported on (b)(6) 2013 that the patient was scheduled for explant of the lead due to infection. The patient was placed on iv vancomycin by infectious disease. The lead was explanted on (b)(6) 2013. Reimplant is planned at a later date.

 
Event Description

The generator analysis was completed on (b)(4) 2013. The diagnostic testing showed that 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 generator.

 
Manufacturer Narrative

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

 
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Brand NamePULSE GEN MODEL 103
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 Key3081131
Report Number1644487-2013-01182
Device Sequence Number1
Product CodeLYJ
Report Source Manufacturer
Source Type Health Professional,Company Representative
Reporter Occupation
Type of Report Initial,Followup
Report Date 03/29/2013
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received04/26/2013
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? No
Device Operator LAY USER/PATIENT
Device EXPIRATION Date07/31/2013
Device MODEL Number103
Device LOT Number201848
Was Device Available For Evaluation? Device Returned To Manufacturer
Date Returned to Manufacturer04/05/2013
Is The Reporter A Health Professional? No
Event Location Other
Date Manufacturer Received04/29/2013
Was Device Evaluated By Manufacturer? Yes
Date Device Manufactured08/15/2011
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: 04/26/2013 Patient Sequence Number: 1
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