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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: CYBERONICS INC PULSE GEN MODEL 104 GENERATOR

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CYBERONICS INC PULSE GEN MODEL 104 GENERATOR Back to Search Results
Model Number 104
Event Date 01/06/2013
Event Type  Injury  
Event Description

On (b)(6) 2013, it was reported that this patient was seen in clinic on this date with an open chest incision and infection. Per the patient's mother, the patient did not pick at the incision site. Clinic notes dated (b)(6) 2013 indicated that the patient's mother noticed on (b)(6) 2013 that the battery incision had opened up and that there was swelling. The patient was seen in the emergency room, bandaged up, and sent home. The patient's mother stated that the patient had a chest x-ray that revealed normal generator placement and an ultrasound looking for abscess that was also normal. The patient was prescribed amoxicillin which improved the swelling significantly; however, while the wound had closed somewhat, it was still slightly open. It was noted that there was a 1/2 centimeter opening in the inferior portion of the patient's chest incision, purulent drainage and culture. There was tenderness with palpitation. Notes from the patient's (b)(6) 2012 appointment did not note any problems with vns. Cultures were taken after five days of antibiotics and returned (b)(6) for (b)(6). On (b)(6) 2013, the patient underwent full explant. The infection was noted to have spread up to the lead site.

 
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 104
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
nydia herzog
100 cyberonics blvd
suite 600
houston , TX 77058
2812287200
MDR Report Key2958323
Report Number1644487-2013-00387
Device Sequence Number1
Product CodeLYJ
Report Source Manufacturer
Source Type Other,Health Professional,Company Representative
Reporter Occupation
Type of Report Initial
Report Date 01/16/2013
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received02/13/2013
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? No
Device Operator LAY USER/PATIENT
Device EXPIRATION Date04/30/2011
Device MODEL Number104
Device LOT Number201114
Was Device Available For Evaluation? No
Is The Reporter A Health Professional? Yes
Event Location Other
Date Manufacturer Received01/16/2013
Was Device Evaluated By Manufacturer? Device Not Returned To Manufacturer
Date Device Manufactured06/10/2009
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: 02/13/2013 Patient Sequence Number: 1
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