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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
Device Problem Low Battery
Event Date 05/23/2017
Event Type  Injury  
Manufacturer Narrative

 
Event Description

Report received that a patient was referred for a generator replacement. It was thought that the battery had depleted since the patient could no longer feel stimulation and the generator could not be interrogated. Over the three months after the battery had likely depleted, the patient gained 20 pounds due to an increased appetite. It was also reported that the patient had a decrease in the quality of her sleep which the patient admitted might be related to anxiety over her generator battery depleting. The patient's generator was later replaced and the reason for replacement was listed as battery depletion on the implant card. No further relevant information has been received to date.

 
Manufacturer Narrative

(b)(4). Describe event or problem, corrected data: initial mdr inadvertently did not include verbiage regarding the available programming history. There was no available programming history for review so the patient's generator history could not be evaluated.

 
Event Description

Further information was received that before the replacement, the company representative was unable to interrogate the device due to battery depletion. The generator was also reportedly discarded after replacement. Further information was received from the patient's neurologist that there was no known preexisting relationship between vns and appetite and weight changes but that there was a possibility vns stimulation helped control these issues. It was also said that the programmer used during the initial failure to program had worked since that event. There was no available programming history data for this patient's generator so the expected battery life and patient settings could not be evaluated. The battery had likely reached a status of intermittent and weakened stimulation until it had completely depleted which caused a lack of therapy during the months preceding the complete depletion. This change in therapy contributed to the weight gain and appetite changes. No further relevant information has been received 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
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 Key7051028
Report Number1644487-2017-04852
Device Sequence Number1
Product CodeLYJ
Report Source Manufacturer
Source Type COMPANY REPRESENTATIVE,HEALTH
Reporter Occupation
Type of Report Initial
Report Date 12/15/2017
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received11/21/2017
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? No
Device Operator LAY USER/PATIENT
Device EXPIRATION Date05/31/2010
Device MODEL Number102
Device LOT Number200807
Was Device Available For Evaluation? No
Is The Reporter A Health Professional? Yes
Was the Report Sent to FDA?
Event Location Other
Date Manufacturer Received11/21/2017
Was Device Evaluated By Manufacturer? Device Not Returned To Manufacturer
Date Device Manufactured05/27/2008
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: 11/21/2017 Patient Sequence Number: 1
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