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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: CYBERONICS - HOUSTON PULSE GEN MODEL 104 GENERATOR

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CYBERONICS - HOUSTON PULSE GEN MODEL 104 GENERATOR Back to Search Results
Model Number 104
Event Date 06/30/2016
Event Type  Injury  
Manufacturer Narrative

(b)(4).

 
Event Description

Following a generator replacement on (b)(6) 2016, patient generator incision opened up the next week. The site opened up enough that the generator was visible. This was noticed on (b)(6) in the evening. Patient underwent another surgery on (b)(6) to redo the incision suture. Patient saw the surgeon on (b)(6) 2016 and everything looked good. No infection noted at this time and patient did take antibiotics prophylactically after the first surgery. The nurse at the group home did not think that the picked at the incision to cause this. Additional information was received that the patient actually had been scratching at the dressing and was sensitive to tegaderm dressing.

 
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Brand NamePULSE GEN MODEL 104
Type of DeviceGENERATOR
Manufacturer (Section D)
CYBERONICS - HOUSTON
100 cyberonics blvd
houston TX 77058
Manufacturer (Section G)
CYBERONICS - HOUSTON
100 cyberonics blvd
suite 600
houston TX 77058
Manufacturer Contact
njemile crawley
100 cyberonics blvd
suite 600
houston , TX 77058
2812287200
MDR Report Key5822996
Report Number1644487-2016-01692
Device Sequence Number1
Product CodeLYJ
Report Source Manufacturer
Source Type COMPANY REPRESENTATIVE,HEALTH
Reporter Occupation
Type of Report Initial
Report Date 07/11/2016
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received07/26/2016
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? No
Device Operator LAY USER/PATIENT
Device EXPIRATION Date10/08/2017
Device MODEL Number104
Device LOT Number203700
Was Device Available For Evaluation? No
Is The Reporter A Health Professional? Yes
Was the Report Sent to FDA?
Event Location Other
Date Manufacturer Received07/11/2016
Was Device Evaluated By Manufacturer? Device Not Returned To Manufacturer
Date Device Manufactured02/11/2016
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: 07/26/2016 Patient Sequence Number: 1
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