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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: CYBERONICS - HOUSTON PULSE GEN MODEL 102R; GENERATOR
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CYBERONICS - HOUSTON PULSE GEN MODEL 102R; GENERATOR Back to Search Results
Model Number 102R
Medical Device Problem Code Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes Unspecified Infection (1930); Tissue Breakdown (2681)
Date of Event 03/15/2019
Type of Reportable Event Serious Injury
Event or Problem Description
A patient was seen in the office and it was observed that the generator had extruded and needed replacement.The patient was going to see the surgeon as soon as possible.It was stated that the physician did not know the cause of the extrusion and that the device was explanted due to infection.No additional, relevant information was received to date.
 
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Brand Name
PULSE GEN MODEL 102R
Common Device Name
GENERATOR
Manufacturer (Section D)
CYBERONICS - HOUSTON
100 cyberonics blvd
houston TX 77058
MDR Report Key8458805
Report Number1644487-2019-00606
Device Sequence Number14217358
Product Code LYJ
UDI-Device Identifier05425025750023
UDI-Public05425025750023
Combination Product (Y/N)N
Initial Reporter StateCA
Initial Reporter CountryUS
PMA/510(K) Number
P970003
Number of Events Summarized1
Summary Report (Y/N)N
Device Implanted Year2015
Device Explanted Year2019
Reporter Type Manufacturer
Report Source company representative,health
Initial Reporter Occupation Physician
Type of Report Initial
Report Date (Section B) 03/27/2019
1 Device was Involved in the Event
1 Patient was Involved in the Event
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Operator of Device Lay User/Patient
Device Expiration Date11/04/2016
Device Model Number102R
Device Lot Number203228
Was Device Available for Evaluation? No
Event Location Other
Type of Report(Section G)Thirty-Day
Initial Date Received by Manufacturer 03/15/2019
Initial Report FDA Received Date03/28/2019
Is This a Single-Use Device that was
Reprocessed and Reused on a Patient? (Y/N)		 No
Patient Sequence Number1
Outcome Attributed to Adverse Event Required Intervention;
Patient Age60 YR
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