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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: CYBERONICS - HOUSTON PULSE GEN MODEL 105 GENERATOR

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CYBERONICS - HOUSTON PULSE GEN MODEL 105 GENERATOR Back to Search Results
Model Number 105
Event Date 01/01/2015
Event Type  Injury  
Event Description

It was reported by the physician the patient had her generator and lead explanted on (b)(6) 2015 due to painful stimulation at the generator site. It was also reported the patient had pain in her left neck at the incision site. It was reported the patient first began having pain around (b)(6) 2015. Attempts for additional relevant information have been unsuccessful to date.

 
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Brand NamePULSE GEN MODEL 105
Type of DeviceGENERATOR
Manufacturer (Section D)
CYBERONICS - HOUSTON
100 cyberonics blvd
houston TX 77058
Manufacturer (Section G)
CYBERONICS - HOUSTON
100 cyberonics blvd
suite 600
houston TX 77058
Manufacturer Contact
njemile crawley
100 cyberonics blvd
suite 600
houston , TX 77058
2812287200
MDR Report Key5051818
Report Number1644487-2015-05690
Device Sequence Number1
Product CodeLYJ
Report Source Manufacturer
Reporter Occupation
Report Date 08/06/2015
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received09/02/2015
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? No
Device Operator LAY USER/PATIENT
Device EXPIRATION Date04/30/2016
Device MODEL Number105
Device LOT Number202951
Was Device Available For Evaluation? No
Is The Reporter A Health Professional? Yes
Was the Report Sent to FDA?
Event Location Other
Date Manufacturer Received08/06/2015
Was Device Evaluated By Manufacturer? Device Not Returned To Manufacturer
Date Device Manufactured06/04/2014
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: 09/02/2015 Patient Sequence Number: 1
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