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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: CYBERONICS, INC. PULSE GEN MODEL 103 GENERATOR

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CYBERONICS, INC. PULSE GEN MODEL 103 GENERATOR Back to Search Results
Model Number 103
Device Problem Migration or Expulsion of Device
Event Date 09/03/2015
Event Type  Injury  
Event Description

It was reported on (b)(6) 2015 the patient had come in the day prior and was complaining of radial arm pain. The vns device was interrogated and system diagnostics were run and everything was fine. It was discussed that the patient had lost over (b)(6) lbs since implantation and the device has moved medially. It is right on her chest bone now. The physician thinks that her arm pain might be due to the device moving and putting pressure on a nerve. He is referring her to a neurosurgeon for a revision of the placement of the generator. No additional relevant information has been received to date.

 
Event Description

The patient did not have her surgery has scheduled. The patient has had medication issues which were a factor in the decision not to perform surgery. No additional relevant information has been received to date.

 
Event Description

Additional information was received that patient is having her device revised due to the fact that the patient has lost weight and the device has migrated. It was also reported the patient is feeling pain and choking during stimulation.

 
Event Description

Patient underwent generator replacement surgery. The explanted generator has not been received to date.

 
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Brand NamePULSE GEN MODEL 103
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 Key5112349
Report Number1644487-2015-05967
Device Sequence Number1
Product CodeLYJ
Report Source Manufacturer
Source Type COMPANY REPRESENTATIVE,CONSUM
Reporter Occupation HEALTH PROFESSIONAL
Type of Report Initial,Followup
Report Date 08/03/2017
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received09/29/2015
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? No
Device Operator LAY USER/PATIENT
Device EXPIRATION Date05/06/2010
Device MODEL Number103
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 Received07/17/2017
Was Device Evaluated By Manufacturer? Device Not Returned To Manufacturer
Date Device Manufactured05/28/2008
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: 09/29/2015 Patient Sequence Number: 1
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