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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: CYBERONICS - HOUSTON PULSE GEN MODEL 102 GENERATOR

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CYBERONICS - HOUSTON PULSE GEN MODEL 102 GENERATOR Back to Search Results
Model Number 102
Device Problem Adverse Event Without Identified Device or Use Problem
Event Date 07/01/2017
Event Type  Injury  
Event Description

It was reported that the patient's device was explanted due to discomfort follow-up showed that the patient was last seen in (b)(6) and the patient's mother reported to the physician that there was skin breakdown where the generator was sticking out of the skin. The generator was returned and product analysis was completed and approved. An open can measurement of the battery voltage determined that the battery was depleted. The end of service condition was the result of normal, expected battery depletion based on the battery life calculation, the electrical test results and the bench evaluation. The device performed according to functional specifications. Analysis of the generator concluded that no abnormal performance or any other type of adverse condition was found. The generator and lead design history records were reviewed for sterilization and both devices were confirmed to have been hp sterilized prior to release. No additional relevant information has been provided to date.

 
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Brand NamePULSE GEN MODEL 102
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 Key6973986
Report Number1644487-2017-04671
Device Sequence Number1
Product CodeLYJ
Report Source Manufacturer
Source Type COMPANY REPRESENTATIVE,HEALTH
Reporter Occupation
Type of Report Initial
Report Date 10/24/2017
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received10/24/2017
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? No
Device Operator LAY USER/PATIENT
Device EXPIRATION Date10/12/2007
Device MODEL Number102
Device LOT Number014585
Was Device Available For Evaluation? Device Returned To Manufacturer
Date Returned to Manufacturer09/25/2017
Is The Reporter A Health Professional? No
Was the Report Sent to FDA?
Event Location Other
Date Manufacturer Received09/29/2017
Was Device Evaluated By Manufacturer? Yes
Date Device Manufactured11/22/2005
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: 10/24/2017 Patient Sequence Number: 1
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