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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 10/01/2013
Event Type  Injury  
Event Description

Clinic notes dated (b)(6) 2013, indicate the patient was seen back that day "poset" chess abscess at the vns pocket. The patient is doing well and shows no signs of infection. Sutures were removed. Clinic notes dated (b)(6) 2013 indicate that there were complications with the vns implant surgery which led to the infection. The infection required vns removal. An analysis was performed on the returned lead portions. The slice mark found on the outer silicone most likely provided the leakage path for the remnants of what appeared to have once been body fluids inside the outer silicone tubing. For the observed inner tubing fluid remnants, there was no obvious path for fluid ingress other than the cut ends that were made during the explanted process. The condition of the returned lead portions is consistent with conditions that typically exist following an explant procedure. No obvious anomalies were noted. The setscrew marks found on the lead connector pin provide evidence that, at one point in time, a good mechanical and electrical connection was present. Continuity checks of the returned lead portions were performed, during the visual analysis, with no discontinuities identified. Based on the findings in the product analysis lab, there is no evidence to suggest an anomaly with the returned portions of the device. Results of diagnostic testing indicated that the battery status indicated ifi=no in the product analysis lab. The battery voltage was 2. 924 volts (not at ifi), as measured during completion of test parameter (b)(4) of the final electrical test. The data in the diagaccumconsumed memory locations revealed that 1. 412% of the battery had been consumed. 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.

 
Event Description

It was reported that the patient was going to undergo explant of the vns system on (b)(6) 2013 due to infection. It was reported that the patient has been on antibiotics. Further follow-up revealed that the patient was admitted to the hospital for iv antibiotic therapy and did not respond as well as the surgeon preferred. Clinic notes dated (b)(6) 2013 indicated that the patient had a right chest abscess with cellulitis. It was noted that the patient was doing well until 3 days prior when he noticed that his chest area became red and swollen and tender to touch. The patient was seen in the emergency room on (b)(6) 2013 and was found to have pus draining from the chest site. The patient was given antibiotics and sent home. The patient was seen by the physician on (b)(6) 2013 and a culture and sensitivity and gram stain were obtained. The gram strain was negative and the patient was admitted to the hospital for further antibiotic therapy. It was noted that the patient had bloody material draining from the wound at the anterior axilla region. The generator and lead were returned for analysis on 11/05/2013. Analysis is underway, but has not been completed to date.

 
Manufacturer Narrative

Device manufacturing records were reviewed. Review of 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
njemile crawley
100 cyberonics blvd
suite 600
houston , TX 77058
2812287200
MDR Report Key3479210
Report Number1644487-2013-03539
Device Sequence Number1
Product CodeLYJ
Report Source Manufacturer
Source Type Health Professional,Company Representative
Reporter Occupation
Type of Report Initial,Followup
Report Date 10/23/2013
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received11/20/2013
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? No
Device Operator LAY USER/PATIENT
Device EXPIRATION Date03/31/2015
Device MODEL Number103
Device LOT Number3592
Was Device Available For Evaluation? Device Returned To Manufacturer
Date Returned to Manufacturer11/05/2013
Is The Reporter A Health Professional? Yes
Event Location Other
Date Manufacturer Received11/20/2013
Was Device Evaluated By Manufacturer? Yes
Date Device Manufactured04/09/2013
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: 11/20/2013 Patient Sequence Number: 1
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