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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: CYBERONICS, INC. PULSE GEN MODEL 105 GENERATOR

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CYBERONICS, INC. PULSE GEN MODEL 105 GENERATOR Back to Search Results
Model Number 105
Device Problem Inadequacy of Device Shape and/or Size
Event Date 07/01/2015
Event Type  Injury  
Manufacturer Narrative

 
Event Description

It was reported on (b)(6) 2015 that the patient had a replacement with a model 105 generator in (b)(6) and is now complaining that the generator is too big. The patient states that she is uncomfortable and that it presses into her armpit. The patient wants the device replaced with a smaller model. It was noted that her md does not agree with this because she is receiving good seizure control, but did refer her to a surgeon for consult. No surgical intervention has been taken or planned to date.

 
Manufacturer Narrative

(b)(4).

 
Event Description

On (b)(6) 2015 it was reported that the patient was re-implanted with a model 103 due to patient discomfort. Attempts have been made for the explanted generator but the device has not been received to date.

 
Event Description

It was reported that the explanted device was discarded and will not be returned for analysis.

 
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Brand NamePULSE GEN MODEL 105
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 Key5016030
Report Number1644487-2015-05552
Device Sequence Number1
Product CodeLYJ
Report Source Manufacturer
Source Type HEALTH PROFESSIONAL
Reporter Occupation PATIENT
Type of Report Followup,Followup,Followup
Report Date 07/27/2015
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received08/19/2015
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? No
Device Operator LAY USER/PATIENT
Device EXPIRATION Date11/12/2016
Device MODEL Number105
Device LOT Number4175
Was Device Available For Evaluation? No
Is The Reporter A Health Professional? No
Was the Report Sent to FDA?
Event Location Other
Date Manufacturer Received10/21/2015
Was Device Evaluated By Manufacturer? Device Not Returned To Manufacturer
Date Device Manufactured12/29/2014
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: 08/19/2015 Patient Sequence Number: 1
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