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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
Event Date 08/22/2014
Event Type  Malfunction  
Event Description

It was reported that during generator re-implant surgery on (b)(6) 2014, the vns patient¿s replacement generator showed an end of service condition after being placed into the generator pocket. The generator was not tested prior to implant. Another generator was used for the case. The surgeon claims that cautery was not used when the generator was presented into the field. The unused generator has not been returned to date.

 
Event Description

The explanted generator was returned to the manufacturer for analysis. An end-of-service warning message was verified and found to be associated with the output being disabled by the pulse generator. Once the output was re-enabled, results of electrical test results demonstrated that the pulse generator was operating within specification. Diagnostic testing indicated the device was operating properly and showed a non-ifi condition. The eos condition was not duplicated once the output was re-enabled. The cause of the eos condition was not determined. Other than the eos condition, there were no adverse functional, mechanical, or visual issues identified with the returned generator.

 
Manufacturer Narrative

Device failure occurred, but did not cause or contribute to death or serious injury.

 
Event Description

Additional programming history was reviewed and decoded which showed that initial interrogation of the device showed 3. 272 volts. Subsequent diagnostics found the device at 1. 937 volts and showing vbat < eos indicating that electrocautery likely struck the device causing it to disable.

 
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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 Key4102486
Report Number1644487-2014-02399
Device Sequence Number1
Product CodeLYJ
Report Source Manufacturer
Source Type Health Professional,Company Representative,COMPANY REPRESENTATIVE
Reporter Occupation HEALTH PROFESSIONAL
Type of Report Initial,Followup,Followup
Report Date 08/22/2014
1 Device Was Involved in the Event
0 PatientS WERE Involved in the Event:
Date FDA Received09/19/2014
Is This An Adverse Event Report? No
Is This A Product Problem Report? Yes
Device Operator HEALTH PROFESSIONAL
Device EXPIRATION Date11/30/2015
Device MODEL Number103
Device LOT Number3836
Was Device Available For Evaluation? Device Returned To Manufacturer
Date Returned to Manufacturer09/19/2014
Is The Reporter A Health Professional? Yes
Was the Report Sent to FDA?
Event Location Other
Date Manufacturer Received05/27/2016
Was Device Evaluated By Manufacturer? Yes
Date Device Manufactured01/08/2014
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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