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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: CYBERONICS, INC. PULSE GEN MODEL 106 GENERATOR

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CYBERONICS, INC. PULSE GEN MODEL 106 GENERATOR Back to Search Results
Model Number 106
Event Date 07/26/2016
Event Type  Injury  
Manufacturer Narrative

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

 
Event Description

It was reported that the following generator replacement surgery the patient presented with a dehiscence wound at the generator incision site. The surgeon denied the presence of an infection. The surgeon believed the dehiscent wound was related to the generator replacement surgery. The manufacturing records of the generator were reviewed and it was observed that the generator was sterilized and passed qc inspection prior to distribution. The generator was turned off and the patient was later referred for generator explant surgery. However no surgical interventions are known to have occurred to date. No additional relevant information has been received to date.

 
Event Description

It was reported that the patient underwent generator explant 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, 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 Key6100938
Report Number1644487-2016-02640
Device Sequence Number1
Product CodeLYJ
Report Source Manufacturer
Reporter Occupation
Type of Report Followup
Report Date 10/20/2016
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received11/14/2016
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? No
Device Operator LAY USER/PATIENT
Device EXPIRATION Date02/10/2018
Device MODEL Number106
Device LOT Number203720
Was Device Available For Evaluation? No
Is The Reporter A Health Professional? No
Was the Report Sent to FDA?
Event Location Other
Date Manufacturer Received11/22/2016
Was Device Evaluated By Manufacturer? Device Not Returned To Manufacturer
Date Device Manufactured03/08/2016
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: 11/14/2016 Patient Sequence Number: 1
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