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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 02/10/2015
Event Type  Malfunction  
Event Description

It was reported that the unused pulse generator showed an ifi condition while still in the packaging. The suspect generator has not been returned to date.

 
Event Description

Additional information was received that the generator premature battery depletion was not thought to be due to cold temperatures, which could cause an inaccurately low battery voltage reading. The generator had been stored inside at room temperature and another generator stored in the exact same conditions showed normal battery voltage. The generator has been received by the manufacturer for analysis. However, analysis has not been completed to date.

 
Event Description

Analysis of the returned generator was completed. After a brief period (30 minutes) at 9°f (-12. 8°c), in an environmental chamber, the packaged generator interrogations and system diagnostic tests showed ifi yes and neos yes after 90 minutes. When the packaged generator had time to stabilize at room temperature (74°f (23. 4°c)), the packaged generator interrogations and system diagnostic tests showed ifi no. The pulse generator was not removed from the original package. There were no performance or any other type of adverse conditions found with the pulse generator. Based on correspondence in the issue file, it appears that only interrogations were performed. It is possible that despite recovery of the battery voltage during the attempted implant, the ifi flag did not clear because a diagnostic test was not performed. Only a diagnostic test will clear/update the battery status flag to reflect the current battery condition.

 
Manufacturer Narrative

 
Manufacturer Narrative

(b)(4). Corrected data: inadvertently did not include the udi on the initial report.

 
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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 Key4577750
Report Number1644487-2015-04074
Device Sequence Number1
Product CodeLYJ
Report Source Manufacturer
Source Type Company Representative
Reporter Occupation
Type of Report Initial,Followup,Followup
Report Date 02/10/2015
1 Device Was Involved in the Event
0 PatientS WERE Involved in the Event:
Date FDA Received03/06/2015
Is This An Adverse Event Report? No
Is This A Product Problem Report? Yes
Device Operator HEALTH PROFESSIONAL
Device EXPIRATION Date11/30/2016
Device MODEL Number105
Device LOT Number203205
Was Device Available For Evaluation? Device Returned To Manufacturer
Date Returned to Manufacturer04/06/2015
Is The Reporter A Health Professional? No
Event Location Other
Date Manufacturer Received04/30/2015
Was Device Evaluated By Manufacturer? Yes
Date Device Manufactured12/19/2014
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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