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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 08/13/2014
Event Type  Injury  
Manufacturer Narrative

Type of reportable event; corrected data: the initial mdr inadvertently selected malfunction instead of serious injury for this field. This mdr is being submitted to correct this data.

 
Event Description

It was reported that the vns patient had been experiencing painful stimulation, dyspnea and coughing with stimulation for the last two weeks. The patient described the pain as beginning at the generator site and then traveling up to the left side of her face to her jaw during stimulation on-times. The patient indicated that the painful stimulation was to the point of wanting the device disabled, so the device was programmed off. A system diagnostic showed normal device function. The patient underwent generator replacement surgery on (b)(6) 2014. The explanted device has not been returned to date. 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 Key4266673
Report Number1644487-2014-03087
Device Sequence Number1
Product CodeMUZ
Report Source Manufacturer
Source Type Consumer,Health Professional,Company Representative
Reporter Occupation PATIENT
Type of Report Initial,Followup
Report Date 10/22/2014
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received11/20/2014
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? No
Device Operator LAY USER/PATIENT
Device EXPIRATION Date07/31/2007
Device MODEL Number102
Device LOT Number013755
Was Device Available For Evaluation? No
Is The Reporter A Health Professional? No
Event Location Other
Date Manufacturer Received11/20/2014
Was Device Evaluated By Manufacturer? Device Not Returned To Manufacturer
Date Device Manufactured08/23/2005
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: 11/20/2014 Patient Sequence Number: 1
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