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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 01/01/2013
Event Type  Injury  
Event Description

It was reported that the vns study patient¿s generator was explanted due to pain on (b)(6) 2014. The patient¿s device was programmed to deliver stimulation four times a day. The patient experienced mild pain when moving, sleeping, and touching the generator site for the past year; however the pain intensified in (b)(6) 2014. The device was programmed off per the patient¿s request but the pain persisted. After the generator was removed, the patient¿s pain was resolved.

 
Manufacturer Narrative

Common device name: type of device product code: this device was implanted to treat rheumatoid arthritis.

 
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Brand NamePULSE GEN MODEL 102
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 Key3705846
Report Number1644487-2014-00780
Device Sequence Number1
Product CodeMUZ
Report Source Manufacturer
Source Type Foreign,Study,Health Professional,Company Representative
Reporter Occupation
Type of Report Initial
Report Date 02/25/2014
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received03/27/2014
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? No
Device Operator LAY USER/PATIENT
Device EXPIRATION Date08/31/2012
Device MODEL Number102
Device LOT Number2790
Was Device Available For Evaluation? No
Event Location Other
Date Manufacturer Received02/25/2014
Was Device Evaluated By Manufacturer? Device Not Returned To Manufacturer
Date Device Manufactured09/08/2010
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: 03/27/2014 Patient Sequence Number: 1
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