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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 10/21/2008
Event Type  Malfunction  
Event Description

Analysis of a generator that was returned was completed on (b)(6) 2014. The battery status indicated ifi = yes, the battery is partially depleted. A review of the internal memory locations within the generator suggests the existence of an error in calculating the device's battery voltage. Electrical test results showed that the pulse generator performed according to functional specifications. Other than the noted condition were no adverse functional, mechanical, or visual issues identified with the returned generator.

 
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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 Key4042218
Report Number1644487-2014-02113
Device Sequence Number1
Product CodeLYJ
Report Source Manufacturer
Source Type Company Representative
Reporter Occupation
Type of Report Initial
Report Date 07/30/2014
1 Device Was Involved in the Event
0 PatientS WERE Involved in the Event:
Date FDA Received08/27/2014
Is This An Adverse Event Report? No
Is This A Product Problem Report? Yes
Device Operator LAY USER/PATIENT
Device EXPIRATION Date10/31/2010
Device MODEL Number103
Device LOT Number2214
Was Device Available For Evaluation? Device Returned To Manufacturer
Date Returned to Manufacturer05/16/2014
Is The Reporter A Health Professional? No
Event Location Other
Date Manufacturer Received07/30/2014
Was Device Evaluated By Manufacturer? Yes
Date Device Manufactured10/21/2008
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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