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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: CYBERONICS, INC. PULSE GEN MODEL 102 GENERATOR

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CYBERONICS, INC. PULSE GEN MODEL 102 GENERATOR Back to Search Results
Model Number 102
Event Date 10/15/2014
Event Type  Injury  
Event Description

It was reported that the vns patient developed an infection following a recent generator replacement surgery on (b)(6) 2014. The patient was given additional antibiotic medication. No known surgical interventions have occurred to date. Review of manufacturing records confirmed sterilization for the generator prior to distribution.

 
Event Description

It was reported that the patient had explant surgery on (b)(6) 2015. The generator and lead were explanted due to wound infection.

 
Event Description

It was reported that re-implant is not being pursued at this time. The physician believes the patient¿s constant scratching at the sites would result in infection occurring again in the future.

 
Event Description

It was reported by the treating physician¿s office that the patient¿s caregiver would not leave the wound alone and subsequently caused the infection. Analysis of the generator was completed. There were no performance or any other type of adverse conditions found with the pulse generator. Except for an abraded opening in the outer tubing, there were no observed product related issues with the returned lead portions. Scanning electron microscopy images of the positive coil show that pitting or electro-etching conditions have occurred at the coil end. The most likely cause for the observed pitting condition is that the generator was not programmed off at the time of explant and therefore delivering therapy to the cut leads. Analysis of the lead revealed dried remnants of what appear to have been fluids/betadine solution inside the inner and outer silicone tubing. No obvious point of entrance was noted other than the identified tubing opening and the end of the returned lead portion. Note that since a portion of the lead (including the electrode array) was not returned for analysis, an evaluation and resulting commentary cannot be made on that portion of the lead. Other than the above mentioned observations and typical wear and explant related observations, no other anomalies were identified in the returned lead portion.

 
Event Description

Although reimplant may occur, it has not occurred to date.

 
Event Description

The patient¿s infected area has still failed to heal completely. The patient will be treated with antibiotic ointment. The electrode portion of the lead was removed on (b)(6) 2015 since the wound was not healing.

 
Manufacturer Narrative

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

 
Manufacturer Narrative

Manufacturer device history records were reviewed. Review of manufacturing records confirmed sterilization for the lead prior to distribution.

 
Manufacturer Narrative

Device available for evaluation, corrected data: the supplemental report #1 inadvertently did not report this data.

 
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Brand NamePULSE GEN MODEL 102
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 Key4293846
Report Number1644487-2014-03190
Device Sequence Number1
Product CodeLYJ
Report Source Manufacturer
Source Type Health Professional,Company Representative
Reporter Occupation HEALTH PROFESSIONAL
Type of Report Initial,Followup,Followup,Followup,Followup
Report Date 11/03/2014
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received12/03/2014
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? No
Device Operator HEALTH PROFESSIONAL
Device EXPIRATION Date12/31/2015
Device MODEL Number102
Device LOT Number202816
Was Device Available For Evaluation? Device Returned To Manufacturer
Date Returned to Manufacturer01/16/2015
Is The Reporter A Health Professional? Yes
Event Location Other
Date Manufacturer Received05/21/2015
Was Device Evaluated By Manufacturer? Yes
Date Device Manufactured02/06/2014
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: 12/03/2014 Patient Sequence Number: 1
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