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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: CYBERONICS INC PULSE GEN MODEL 103

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CYBERONICS INC PULSE GEN MODEL 103 Back to Search Results
Model Number 103
Event Date 04/10/2009
Event Type  Malfunction  
Event Description

Attempts were made for operative notes for the implant and explant of the generator however they will not be provided as it is against their policy.

 
Event Description

A review of pt programming data revealed that during the pt's initial follow up visit ((b)(6) 2009) after implant surgery ((b)(6) 2009) a "vbat < eos threshold" warning message was received indicating that the pt's demipulse generator was likely in the presence of electrocautery causing an asic latch-up condition during the implant procedure. As a result of this exposure the capacity of the generators battery was altered leading to an atypical depletion state. The generator was returned and reported in mdr # 1644487-2011-01531 due to a premature eos allegation. An end-of-service warning message was verified in the product analysis lab and found to be associated with the output being disabled by the pulse generator. Post burn-in electrical test results showed that the pulse generator performed according to functional specifications. There was a capacitor that was measured to be out-specification but had no adverse effect on device functionality. The battery is depleted, 1. 56 volts as measured with the can removed and battery still attached to the pcb. The data in the memory locations revealed that 34. 928% of the battery had been consumed.

 
Manufacturer Narrative

Date received by manufacturer (mo/day/yr), corrected data. Follow-up report #1 inadvertently listed the aware date as (b)(6) 2011, which was the aware date for the initial report. The correct aware date for the follow-up #1 report should have been (b)(6) 2011.

 
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Brand NamePULSE GEN MODEL 103
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
nydia grimes
100 cyberonics blvd
suite 600
houston , TX 77058
2812287200
MDR Report Key2211867
Report Number1644487-2011-01839
Device Sequence Number1
Product CodeLYJ
Report Source Manufacturer
Source Type Health Professional,Company Representative
Reporter Occupation
Type of Report Initial,Followup,Followup
Report Date 07/20/2011
1 Device Was Involved in the Event
0 PatientS WERE Involved in the Event:
Date FDA Received08/10/2011
Is This An Adverse Event Report? No
Is This A Product Problem Report? Yes
Device Operator LAY USER/PATIENT
Device EXPIRATION Date01/19/2011
Device MODEL Number103
Device LOT Number201025
Was Device Available For Evaluation? Yes
Date Returned to Manufacturer06/21/2011
Is The Reporter A Health Professional? No
Date Manufacturer Received09/26/2011
Was Device Evaluated By Manufacturer? Yes
Date Device Manufactured02/01/2009
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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