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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: CYBERONICS, INC. PULSE GEN MODEL 105 GENERATOR

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CYBERONICS, INC. PULSE GEN MODEL 105 GENERATOR Back to Search Results
Model Number 105
Event Date 01/26/2015
Event Type  Injury  
Event Description

On (b)(6) 2015, it was reported that the patient was seen in the surgeon¿s office and an infection was observed at the chest incision site. The patient was scheduled for explant of the generator. The generator was explanted on (b)(6) 2015 due to the generator pocket infection. Operative notes were received from the (b)(4) 2015 explant surgery. It was noted that the skin incision was blistering on the lateral aspect and there was fairly thin fluid that was purulent/sanguinous coming out of the incision. No frank pus was found. The infected tissue was fully debrided and the generator was removed. The explanted generator was returned for product analysis on 02/26/2015. Product analysis is underway and has not yet been completed.

 
Event Description

Product analysis was completed on the generator. The dhr shows that the pulse generator passed all specifications before it was released. A comprehensive automated electrical evaluation showed that the pulse generator performed according to functional specifications. There were no performance or any other type of adverse conditions found with the pulse generator.

 
Event Description

Additional information was received that the patient was not doing any better following a one month course of antibiotics. The neck incision site was still swollen, with an area that had a hard knot and appeared as though it had come to a head. No additional known interventions or re-implant have occurred to date.

 
Manufacturer Narrative

(b)(4). Corrected data: inadvertently did not include the udi on the initial report.

 
Event Description

Additional information was received that the patient's lead was explanted on (b)(6) 2015 due to infection, which apparently had spread to the lead. Review of the lead device history record confirmed sterility and no non conformances were found.

 
Event Description

Additional information was received that the patient was on antibiotics for 14 days following the (b)(6) 2015 explant surgery due to infection. The patient was referred for re-implant but developed a cough and fever and the patient's caregiver noticed the chest incision site begin to bubble up again however it was reportedly not red or warm to touch. Thus, the patient went to the emergency room, where an x-ray was taken and it was stated that the patient had pneumonia and he was put on more antibiotics. No additional known interventions or re=implant have occurred to date.

 
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Brand NamePULSE GEN MODEL 105
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
njemile crawley
100 cyberonics blvd
suite 600
houston , TX 77058
2812287200
MDR Report Key4570484
Report Number1644487-2015-04041
Device Sequence Number1
Product CodeLYJ
Report Source Manufacturer
Source Type Consumer,Health Professional,Company Representative
Reporter Occupation HEALTH PROFESSIONAL
Type of Report Initial,Followup,Followup,Followup,Followup
Report Date 02/10/2015
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received03/04/2015
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? No
Device Operator LAY USER/PATIENT
Device EXPIRATION Date09/30/2016
Device MODEL Number105
Device LOT Number4092
Was Device Available For Evaluation? Device Returned To Manufacturer
Date Returned to Manufacturer02/26/2015
Is The Reporter A Health Professional? Yes
Event Location Other
Date Manufacturer Received07/15/2015
Was Device Evaluated By Manufacturer? Yes
Date Device Manufactured10/14/2014
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: 03/04/2015 Patient Sequence Number: 1
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