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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 06/10/2013
Event Type  Malfunction  
Event Description

It was reported that the patient underwent explant after experiencing a severe wound infection. It was reported that the patient was seen at a hospital and was given antibiotics. Then approximately a month and a half later, the patient was seen by the physician to have the device explanted. It was reported that cultures were negative, but that they were most likely negative due to the antibiotics the patient took. The physician indicated that the patient may have induced the infection by "scrubbing" the infection and because of his low socio-economic status. Further follow-up revealed that the patient experienced a focal axillar dehiscence three weeks post op which had reported healed after a few days. It was reported that two months post op the patient experienced major wound dehiscence with purulent discharge. Attempts to have the device returned for analysis have been unsuccessful to date. It was reported that the hospital is refusing to release the device.

 
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 102
Type of DeviceGENERATOR
Manufacturer (Section D)
CYBERONICS INC
100 cyberonics blvd
houston TX 77058
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 Key3355839
Report Number1644487-2013-02782
Device Sequence Number1
Product CodeLYJ
Report Source Manufacturer
Source Type Foreign,Health Professional,Company Representative
Reporter Occupation
Type of Report Initial
Report Date 08/20/2013
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received09/18/2013
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? No
Device Operator LAY USER/PATIENT
Device EXPIRATION Date08/31/2013
Device MODEL Number102
Device LOT Number201870
Was Device Available For Evaluation? No
Is The Reporter A Health Professional? Yes
Event Location Other
Date Manufacturer Received08/20/2013
Was Device Evaluated By Manufacturer? Device Not Returned To Manufacturer
Date Device Manufactured09/07/2011
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: 09/18/2013 Patient Sequence Number: 1
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