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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: CYBERONICS, INC. PULSE GEN MODEL 103 GENERATOR

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CYBERONICS, INC. PULSE GEN MODEL 103 GENERATOR Back to Search Results
Model Number 103
Device Problem Detachment Of Device Component
Event Date 10/03/2017
Event Type  Malfunction  
Event Description

Report received that during an implant procedure, the septum plug was incidentally removed. Further information was received that the septum plug was already removed when the surgeon went to place the generator in the patient's pocket. The surgeon indicated that nothing unique occurred during tightening or retracting the setscrew. It was later reported that the generator with the detached plug was implanted. A system diagnostic test was taken in the or and showed normal impedance, so the surgeon decided to implant the generator. The removed plug was received by the manufacturer but analysis has not been completed to date. A review of the generator device history record indicated it had passed all quality inspections prior to release for distribution. No further relevant information has been obtained.

 
Event Description

Product analysis was completed on the returned generator septum plug. The septum was not cored, however slight damage to the septum was observed. This damage was consistent with damage found after surgical tool manipulation. The septum's overall diameter, cap diameter, and width measurements were taken. With the exception to the damage seen, the septum met all specification requirements. No anomalies were found. The generator was not returned and therefore it was not analyzed. No further relevant information has been received to date.

 
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Brand NamePULSE GEN MODEL 103
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 Key6988583
Report Number1644487-2017-04702
Device Sequence Number1
Product CodeLYJ
Report Source Manufacturer
Source Type COMPANY REPRESENTATIVE,FOREIG
Reporter Occupation
Type of Report Initial
Report Date 11/27/2017
1 Device Was Involved in the Event
0 PatientS WERE Involved in the Event:
Date FDA Received10/30/2017
Is This An Adverse Event Report? No
Is This A Product Problem Report? Yes
Device Operator HEALTH PROFESSIONAL
Device EXPIRATION Date07/05/2018
Device MODEL Number103
Device LOT Number300467
Was Device Available For Evaluation? No
Is The Reporter A Health Professional? Yes
Was the Report Sent to FDA?
Event Location Other
Date Manufacturer Received11/01/2017
Was Device Evaluated By Manufacturer? Device Not Returned To Manufacturer
Date Device Manufactured09/12/2016
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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