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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: CYBERONICS, INC. PULSE GEN MODEL 105 GENERATOR

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CYBERONICS, INC. PULSE GEN MODEL 105 GENERATOR Back to Search Results
Model Number 105
Device Problem Detachment Of Device Component
Event Date 05/31/2017
Event Type  Malfunction  
Event Description

It was reported that during the patient¿s surgical case, the septum plug and setscrew popped out of the new intended replacement generator. Prior to this occurrence, diagnostic results of the generator connected to the lead outside the implant pocket were within normal limits. It was at the point, the screwdriver was removed from the setscrew that the septum plug came out. The surgeon tried to put the septum plug back in, but it would not stay in. The setscrew also came out with reportedly little or no manipulation. The generator was not used in the patient¿s implant case. The generator device history record was reviewed by the manufacturer. It was found that all quality tests passed prior to distribution. The unused generator has not been received by the manufacturer to date. No additional pertinent information has been received to date.

 
Manufacturer Narrative

Corrected data: the initial report inadvertently listed the wrong contact as the initial reporter.

 
Event Description

The generator was received by the manufacturer for product analysis. Product analysis was completed on the returned generator. Visual examination showed only observations consistent with the explant process; no surface abnormalities were noted on this device. Both interrogation and system diagnostic tests were performed. An electrical load was attached to the pulse generator, and results of diagnostic test demonstrate that accurate resistance measurements were obtained. A comprehensive automated electrical evaluation showed that the pulse generator performed according to functional specifications. The battery measured 2. 995 volts during functional testing and showed an ifi=no condition. The internal device data showed that 1. 519% of the battery had been consumed. The microscopic visual assessment of the septum shows no visual anomalies. The visual assessment of the returned set screw shows mechanical wear to the set screw socket, suggesting numerous insertion attempts. The socket was not stripped. The set screw also shows indention marks on the bottom of the set screw, which indicates that a lead pin or test resistor was secured with the returned set screw. Manipulation of the torque wrench may have been the contributing factor for the component detachment. The septum and septum cavity met all dimensional requirements. Besides the observed detached components, there was no evidence of adverse conditions found with the pulse generator.

 
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Brand NamePULSE GEN MODEL 105
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 Key6652810
Report Number1644487-2017-04013
Device Sequence Number1
Product CodeLYJ
Report Source Manufacturer
Source Type COMPANY REPRESENTATIVE,HEALTH
Reporter Occupation
Type of Report Initial
Report Date 07/18/2017
1 Device Was Involved in the Event
0 PatientS WERE Involved in the Event:
Date FDA Received06/20/2017
Is This An Adverse Event Report? No
Is This A Product Problem Report? Yes
Device Operator HEALTH PROFESSIONAL
Device EXPIRATION Date05/03/2018
Device MODEL Number105
Device LOT Number4851
Was Device Available For Evaluation? Device Returned To Manufacturer
Date Returned to Manufacturer06/21/2017
Is The Reporter A Health Professional? Yes
Was the Report Sent to FDA?
Event Location Other
Date Manufacturer Received06/21/2017
Was Device Evaluated By Manufacturer? Yes
Date Device Manufactured05/12/2016
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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