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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: CYBERONICS, INC. PULSE GEN MODEL 102R GENERATOR

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CYBERONICS, INC. PULSE GEN MODEL 102R GENERATOR Back to Search Results
Model Number 102R
Device Problem Detachment Of Device Component
Event Date 05/12/2017
Event Type  Malfunction  
Event Description

During a generator replacement surgery due to battery depletion, it was reported that when the surgeon removed the generator from the patient, its septum plug fell out. The physician did not manipulate the device in any way. System diagnostics prior to surgery were within normal limits. The device history records were reviewed and it was confirmed that the generator passed all functional tests and quality inspection prior to final release. No further relevant information has been received to date. The product was received but product analysis has not been completed to date.

 
Event Description

Product analysis was completed on the suspect generator and it was found that the septum plugs of the generator were in place. Instead, the header was found to be detached. Product analysis found that the header detachment most likely occurred during the explant procedure and it was possible that the feedthru wires in the header were broken during the explant procedure. After test wires were used to attach the generator to the final test fixture, the device performed according to functional specifications. No further relevant information has been received to date.

 
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Brand NamePULSE GEN MODEL 102R
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 Key6616010
Report Number1644487-2017-03933
Device Sequence Number1
Product CodeLYJ
Report Source Manufacturer
Source Type COMPANY REPRESENTATIVE,HEALTH
Reporter Occupation HEALTH PROFESSIONAL
Type of Report Initial
Report Date 07/14/2017
1 Device Was Involved in the Event
0 PatientS WERE Involved in the Event:
Date FDA Received06/06/2017
Is This An Adverse Event Report? No
Is This A Product Problem Report? Yes
Device Operator LAY USER/PATIENT
Device EXPIRATION Date07/31/2010
Device MODEL Number102R
Device LOT Number2163
Was Device Available For Evaluation? Device Returned To Manufacturer
Date Returned to Manufacturer05/19/2017
Is The Reporter A Health Professional? Yes
Was the Report Sent to FDA?
Event Location Other
Date Manufacturer Received06/19/2017
Was Device Evaluated By Manufacturer? Yes
Date Device Manufactured07/29/2008
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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