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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 Adverse Event Without Identified Device or Use Problem
Event Date 02/21/2017
Event Type  Injury  
Manufacturer Narrative

(b)(4).

 
Event Description

Since generator replacement surgery, patient has been experiencing constipation, urinary retention, decreased vocal volume and loss of appetite. These symptoms resolved when a magnet was placed over the generator and returned when the magnet was removed. Grandparents presented video recorded just prior to being turned off and following turning back on that support this (patient's voice volume returned to a normal baseline). At the time of generator replacement, patient had not experienced the above side effects. At the time of replacement, the patient¿s new vns settings were the same as the previous settings. The physician decreased the pulse width based on this observation and grandparents are to continue monitoring the patient. No additional relevant information has been received.

 
Event Description

Additional information was received that there have been no changes to medications since the generator was replaced. Patient does not have history of constipation prior to generator replacement. After replacement, patient had significant constipation that was unresponsive to medical intervention. When generator was turned off for a few hours over multiple days constipation resolved, the generator is currently off and there is no constipation. Consult with urology for evaluation of urinary retention noted that constipation was the etiology of retention. With resolution of constipation, urinary retention has resolved. Decreasing settings, short trial periods of turning the generator off followed by permanent turn off were performed as interventions. Two view chest x-rays were taken to assess for wire integrity, which was negative. Upon recent follow up with the family, all symptoms have resolved since turning the device off except for decreased appetite. Patient's vocal volume has also returned to normal with device disablement. Per the nurse practitioner, review of records indicate that weight loss secondary to decreased appetite developed with the introduction of a medication. This started prior to vns generator change. The nurse practitioner is currently lowering medication as a means to improve patient's appetite.

 
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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 Key6639108
Report Number1644487-2017-03972
Device Sequence Number1
Product CodeLYJ
Report Source Manufacturer
Source Type COMPANY REPRESENTATIVE,HEALTH
Reporter Occupation OTHER HEALTH CARE PROFESSIONAL
Type of Report Initial
Report Date 07/18/2017
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received06/13/2017
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? No
Device Operator LAY USER/PATIENT
Device EXPIRATION Date04/02/2017
Device MODEL Number105
Device LOT Number4909
Was Device Available For Evaluation? No
Is The Reporter A Health Professional? Yes
Was the Report Sent to FDA?
Event Location Other
Date Manufacturer Received06/22/2017
Was Device Evaluated By Manufacturer? Device Not Returned To Manufacturer
Date Device Manufactured06/29/2016
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: 06/13/2017 Patient Sequence Number: 1
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