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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 Insufficient Information
Event Date 03/31/2014
Event Type  Injury  
Event Description

It was reported that the patient experienced a loss of appetite and weight loss. The device was programmed off as a result. It was reported that the events were probably related to device surgery and possibly related to device stimulation. The events were noted to be ongoing. It was noted that the device was disabled at the patient's request and that evaluation would be performed on whether the device would be programmed back on or if is dropped completely. No additional relevant information has been received to date.

 
Event Description

It was reported that the serial number of the generator is unknown and the serial number previously provided belonged to the lead, not the generator.

 
Event Description

Additional information was received stating that the vns study patient did not continue with the study as the loss of appetite and weight loss had not resolved.

 
Manufacturer Narrative

 
Manufacturer Narrative

Corrected data: this date was inadvertently left off of follow-up mfr. Report #01. The date should have been reported as 07/10/2014. Follow-up mfr. Report #01 was not a late submission.

 
Manufacturer Narrative

Corrected data: new information received that the suspect device information is unknown.

 
Event Description

Further information was received indicating that the loss of weight had resolved. The event stopped on (b)(6) 2014. The patient recovered.

 
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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 Key3886929
Report Number1644487-2014-01556
Device Sequence Number1
Product CodeLYJ
Report Source Manufacturer
Source Type Foreign,Study,Health Professional,Company Representative,COMPANY REPRESENT
Reporter Occupation
Type of Report Initial,Followup,Followup,Followup,Followup
Report Date 05/23/2014
1 Device Was Involved in the Event
0 PatientS WERE Involved in the Event:
Date FDA Received06/20/2014
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? No
Device Operator LAY USER/PATIENT
Device EXPIRATION Date11/30/2014
Device MODEL Number102
Device LOT Number3492
Was Device Available For Evaluation? No
Is The Reporter A Health Professional? No
Was the Report Sent to FDA?
Event Location Other
Date Manufacturer Received10/13/2015
Was Device Evaluated By Manufacturer? Device Not Returned To Manufacturer
Date Device Manufactured12/13/2012
Is The Device Single Use? Yes
Is this a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial

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