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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 Device Operates Differently Than Expected
Event Date 11/12/2015
Event Type  Injury  
Event Description

It was reported that the patient swiped her magnet and the stimulation was so strong it made her cry. Subsequent device stimulation (normal mode and magnet mode) was painful. The magnet was used to disable the device and the patient was seen by the physician. Device diagnostics were within normal limits and the device was not at end of service. The patient was sent for x-rays. The patient underwent generator and lead replacement due to the painful and shocking stimulation. The explanted devices have not been received for analysis to date.

 
Event Description

The generator and lead were received for analysis. Analysis of the generator was completed on 01/04/2015. A comprehensive automated electrical evaluation showed that the pulse generator performed according to functional specifications. The battery showed ifi=no condition. There were no performance or any other type of adverse conditions found with the pulse generator.

 
Event Description

Analysis of the lead was completed on 01/11/2016. Note that since the electrode array portion was not returned for analysis, an evaluation and resulting commentary cannot be made on that portion of the lead. Other than typical wear and explant related observations, no anomalies were identified in the returned lead portion.

 
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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 Key5272254
Report Number1644487-2015-06667
Device Sequence Number1
Product CodeLYJ
Report Source Manufacturer
Reporter Occupation
Type of Report Followup,Followup
Report Date 11/12/2015
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received12/07/2015
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? No
Device Operator LAY USER/PATIENT
Device EXPIRATION Date10/31/2015
Device MODEL Number105
Device LOT Number202722
Was Device Available For Evaluation? Device Returned To Manufacturer
Date Returned to Manufacturer12/11/2015
Is The Reporter A Health Professional? Yes
Was the Report Sent to FDA?
Event Location Other
Date Manufacturer Received01/11/2016
Was Device Evaluated By Manufacturer? Yes
Date Device Manufactured11/15/2013
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: 12/07/2015 Patient Sequence Number: 1
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