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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: CYBERONICS - HOUSTON PULSE GEN MODEL 106 GENERATOR

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CYBERONICS - HOUSTON PULSE GEN MODEL 106 GENERATOR Back to Search Results
Model Number 106
Event Date 05/04/2016
Event Type  Injury  
Manufacturer Narrative

Suspect medical device udi: (b)(4).

 
Event Description

It was reported that the generator site was open and the generator was exposed. The patient was recently implanted on (b)(6) 2016. The patient was then referred for surgery to irrigate the site and close the incision. Further follow-up found that the patient has a history of picking at his skin during a seizure. The patient reported to the neurologist that he had a seizure and afterwards the generator incision was found to be open. The patient underwent surgery where the incision site was irrigated with antibiotic solution and the incision was closed. The generator was not replaced during this surgery. No additional relevant information has been received to date.

 
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Brand NamePULSE GEN MODEL 106
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 Key5718792
Report Number1644487-2016-01314
Device Sequence Number1
Product CodeLYJ
Report Source Manufacturer
Reporter Occupation
Report Date 05/18/2016
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received06/10/2016
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? No
Device Operator LAY USER/PATIENT
Device EXPIRATION Date01/04/2018
Device MODEL Number106
Device LOT Number4697
Was Device Available For Evaluation? No
Is The Reporter A Health Professional? Yes
Was the Report Sent to FDA?
Event Location Other
Date Manufacturer Received05/18/2016
Was Device Evaluated By Manufacturer? Device Not Returned To Manufacturer
Date Device Manufactured01/21/2016
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: 06/10/2016 Patient Sequence Number: 1
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