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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: CYBERONICS, INC. PULSE GEN MODEL 102 GENERATOR

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CYBERONICS, INC. PULSE GEN MODEL 102 GENERATOR Back to Search Results
Model Number 102
Event Date 10/06/2014
Event Type  Injury  
Event Description

It was reported that the surgical intervention was not taken to preclude a serious injury. It is unknown if the patient's pain with device stimulation has resolved as the patient has not been seen by the physician since generator replacement.

 
Event Description

Additional information was received that the patient has been seizure free for the past two months.

 
Event Description

It was reported that the vns patient began experiencing painful stimulation from the generator site up to the neck after experiencing a fall. The patient went to the er on (b)(6) 2014 due to intolerable pain and was given pain medication. Clinic notes were received indicating that the patient was referred for surgery although diagnostics showed normal device function at the time. The notes briefly mention that patient¿s painful stimulation. An implant card was received indicating that the patient underwent generator replacement surgery on (b)(6) 2014. The explanted generator was returned to the manufacturer for analysis which concluded proper functionality of the pulse generator and that no abnormal performance or any other type of adverse condition was found. The device performed according to functional specifications. Attempts for additional relevant information have been unsuccessful to date.

 
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Brand NamePULSE GEN MODEL 102
Type of DeviceGENERATOR
Manufacturer (Section D)
CYBERONICS, INC.
100 cyberonics blvd
houston TX 77058 770
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 Key4243940
Report Number1644487-2014-02989
Device Sequence Number1
Product CodeLYJ
Report Source Manufacturer
Source Type Consumer,Health Professional,Company Representative
Reporter Occupation PATIENT
Type of Report Initial,Followup,Followup
Report Date 10/13/2014
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received11/11/2014
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? No
Device Operator LAY USER/PATIENT
Device EXPIRATION Date07/31/2008
Device MODEL Number102
Device LOT Number016066
Was Device Available For Evaluation? Device Returned To Manufacturer
Date Returned to Manufacturer10/29/2014
Is The Reporter A Health Professional? No
Event Location Other
Date Manufacturer Received12/11/2014
Was Device Evaluated By Manufacturer? Yes
Date Device Manufactured09/25/2006
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: 11/11/2014 Patient Sequence Number: 1
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