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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
Event Date 08/05/2014
Event Type  Malfunction  
Event Description

It was reported that the patient had surgery on (b)(6) 2014 for device repositioning due to patient discomfort, with no replacement planned. It was then reported that during this generator repositioning, a plasma blade accidently made contact with the generator. Diagnostics run in the or then revealed and end of service status, which was not seen prior to surgery. The generator was therefore replaced. Device manufacturing labeling indicates user of electrosurgery [electrocautery or radio frequency (rf) ablation devices] may damage the generator. The product was returned. However, analysis has not been completed to date.

 
Event Description

Analysis of the returned generator was completed. 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. Results of diagnostic testing indicated that the battery status was ok. Other than the noted condition, there were no adverse functional, mechanical, or visual issues identified with the returned generator.

 
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Brand NamePULSE GEN MODEL 105
Type of DeviceGENERATOR
Manufacturer (Section D)
CYBERONICS, INC.
100 cyberonics blvd
houston TX 77058 770
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 Key4055889
Report Number1644487-2014-02178
Device Sequence Number1
Product CodeLYJ
Report Source Manufacturer
Source Type Health Professional,Company Representative
Reporter Occupation
Type of Report Initial,Followup
Report Date 08/07/2014
1 Device Was Involved in the Event
0 PatientS WERE Involved in the Event:
Date FDA Received09/03/2014
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 Number105
Device LOT Number3840
Was Device Available For Evaluation? Device Returned To Manufacturer
Date Returned to Manufacturer08/22/2014
Is The Reporter A Health Professional? Yes
Event Location Other
Date Manufacturer Received09/22/2014
Was Device Evaluated By Manufacturer? Yes
Date Device Manufactured01/14/2014
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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