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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
Device Problems Failure to Interrogate ; Battery Problem
Event Date 03/03/2014
Event Type  Malfunction  
Event Description

It was reported that the vns patient¿s device could not be interrogated. Generator replacement surgery was scheduled due to suspected end of service. Additional information was received stating that the neurosurgeon¿s wand battery needed to be replaced. After the battery was replaced, the wand was functioning properly which indicates that the wand battery likely caused the failure to communicate. Additionally, the doctor¿s office planned to contact the patient to inform him surgery was no longer required. With the available information, no definitive conclusions can be made. The patient has not been seen to confirm that the generator could be communicated with since the initial report. Review of the available programming history showed that the last known settings were from (b)(6) 2013.

 
Manufacturer Narrative

Device manufacturing records and available programming and diagnostic history were reviewed. Review of manufacturing records confirmed that the generator passed all functional tests prior to distribution.

 
Event Description

It was reported that the patient was seen by the physician and the device was successfully interrogated. The battery status was reported to be at ifi=yes on (b)(6) 2015. The patient was referred for prophylactic battery replacement. The patient underwent prophylactic generator replacement on (b)(6) 2015. Explanted product has not been received to-date.

 
Manufacturer Narrative

Evaluation codes, corrected data: the evaluation conclusion code inadvertently was reported on the initial report.

 
Event Description

It was reported that the battery was at near end-of-service = no. The explanted generator was discarded and will not be returned for analysis.

 
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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 Key3710780
Report Number1644487-2014-00831
Device Sequence Number1
Product CodeLYJ
Report Source Manufacturer
Source Type Health Professional,Company Representative,COMPANY REPRESENTATIVE
Reporter Occupation
Type of Report Initial,Followup,Followup
Report Date 03/03/2014
1 Device Was Involved in the Event
0 PatientS WERE Involved in the Event:
Date FDA Received03/31/2014
Is This An Adverse Event Report? No
Is This A Product Problem Report? Yes
Device Operator LAY USER/PATIENT
Device EXPIRATION Date01/31/2013
Device MODEL Number103
Device LOT Number201683
Was Device Available For Evaluation? No
Is The Reporter A Health Professional? No
Was the Report Sent to FDA?
Event Location Other
Date Manufacturer Received07/24/2015
Was Device Evaluated By Manufacturer? Device Not Returned To Manufacturer
Date Device Manufactured02/10/2011
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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