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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 04/28/2014
Event Type  Injury  
Event Description

It was reported that the patient underwent generator replacement. It was reported that the surgeon wanted the device discarded because it was infected. No analysis can be performed as the device was discarded.

 
Event Description

It was reported that the vns patient¿s generator incision site was red and leaking yellow fluid. The patient did not have any fever or pain. Further follow-up revealed that the generator could be visualized through a pin-sized hole at the patient¿s generator site. Yellow fluid was reported to be draining from the site. Cultures were negative. The patient was given an antibiotic regiment. No known surgical interventions have occurred to date. Review of manufacturing records confirmed sterilization for both the generator and lead prior to distribution.

 
Manufacturer Narrative

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

 
Event Description

Clinic notes were received for the vns patient¿s office visit with the neurosurgeon on (b)(6) 2014. The notes indicate that the patient developed a dehiscence at the generator site several weeks prior to the office visit. The dehiscence had been draining either yellow or clear fluid. Cultures showed only normal skin flora at the generator site. Antibiotics have not been helpful and the patient continued to have drainage. The patient was referred for surgery for wound debridement and deeper generator placement. No known surgical interventions have occurred to date.

 
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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 Key3824799
Report Number1644487-2014-01335
Device Sequence Number1
Product CodeLYJ
Report Source Manufacturer
Source Type Consumer,Health Professional,Company Representative
Reporter Occupation PATIENT
Type of Report Initial,Followup,Followup
Report Date 04/28/2014
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received05/21/2014
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 Number202296
Was Device Available For Evaluation? No
Is The Reporter A Health Professional? No
Event Location Other
Date Manufacturer Received07/07/2014
Was Device Evaluated By Manufacturer? Device Not Returned To Manufacturer
Date Device Manufactured11/26/2012
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: 05/21/2014 Patient Sequence Number: 1
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