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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 Human-Device Interface Problem
Event Date 10/23/2015
Event Type  Injury  
Manufacturer Narrative

(b)(4).

 
Event Description

It was reported via voicemail message from the patient that the patient had a newer model generator implanted but was "having a lot of trouble" and "does not feel comfortable with the way things turned out". Additional information was received that the patient had a dehiscence wound at the generator site from her replacement surgery (b)(6) 2015. Additional information was received that the patient did not believe the surgeon properly closed the incision. Additional information was received that the patient is being referred for generator/lead replacement due to pain in her neck where the lead is and when she moves her head to the left or looks up. Patient has also reported difficulty eating and chewing and states that she has lost weight since implant. No known surgical interventions have occurred to date. No additional relevant information has been obtained to date.

 
Event Description

Additional information was received that the surgeon stated that everything appeared normal with the patient's implant after observing x-rays. The device had still not been turned on as of (b)(6) 2015. No additional relevant information has been obtained 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 Key5250260
Report Number1644487-2015-06567
Device Sequence Number1
Product CodeLYJ
Report Source Manufacturer
Source Type COMPANY REPRESENTATIVE,CONSUM
Reporter Occupation PATIENT
Type of Report Initial,Followup
Report Date 11/03/2015
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received11/25/2015
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? No
Device Operator LAY USER/PATIENT
Device EXPIRATION Date09/15/2016
Device MODEL Number102
Device LOT Number4094
Was Device Available For Evaluation? No
Is The Reporter A Health Professional? No
Was the Report Sent to FDA?
Event Location Other
Date Manufacturer Received12/09/2015
Was Device Evaluated By Manufacturer? Device Not Returned To Manufacturer
Date Device Manufactured09/28/2015
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: 11/25/2015 Patient Sequence Number: 1
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