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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: CYBERONICS, INC. PULSE GEN MODEL 102R GENERATOR

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CYBERONICS, INC. PULSE GEN MODEL 102R GENERATOR Back to Search Results
Model Number 102R
Device Problem Communication or Transmission Problem
Event Date 05/31/2017
Event Type  Injury  
Event Description

It was reported from the patient¿s full vns replacement surgery that, preoperatively, the patient had pain from a shocking sensation with device diagnostics and lost consciousness for about 30 seconds. The patient¿s behavior was described ¿as if he was having a seizure. ¿ the full diagnostic reading could not be collected due to the poor tolerability of the diagnostic test. It was later clarified that the patient¿s behavior during diagnostic test was that he was ¿incoherent for about 30 seconds¿ but soon recovered. The vns was not disabled prior to surgery. During dissection of the old leads, the patient experienced an episode of asystole while the nerve was being manipulated. The device was disabled at that time to remove it was a variable. The placement of the new leads and generator occurred without incident. The patient¿s explanted lead and generator were reported to have been discarded. Therefore, device return is not expected. Review of the programming history from the surgery showed that a faulted system diagnostic test occurred preoperatively that led to an unintended change of settings. These settings were not resolved until the generator was disabled. No additional pertinent information has been received to date.

 
Event Description

Follow up with the patient¿s surgeon showed that the preoperative ¿episode¿ experienced during the vns diagnostic test represented syncope with the patient being unresponsive for a few seconds. The surgeon knew of no other contributing factors besides vns stimulation. The patient was stated to have fully recovered without intervention and that the episode was assessed to not represent a serious injury. To date, not further pertinent information has been received regarding the intraoperative asystole.

 
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Brand NamePULSE GEN MODEL 102R
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 Key6652801
Report Number1644487-2017-04012
Device Sequence Number1
Product CodeLYJ
Report Source Manufacturer
Source Type COMPANY REPRESENTATIVE,HEALTH
Reporter Occupation
Type of Report Initial
Report Date 07/19/2017
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received06/20/2017
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? No
Device Operator LAY USER/PATIENT
Device EXPIRATION Date02/07/2007
Device MODEL Number102R
Device LOT Number12240
Was Device Available For Evaluation? No
Is The Reporter A Health Professional? Yes
Was the Report Sent to FDA?
Event Location Other
Date Manufacturer Received07/18/2017
Was Device Evaluated By Manufacturer? Device Not Returned To Manufacturer
Date Device Manufactured03/15/2015
Is The Device Single Use? Yes
Is this a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial

Patient TREATMENT DATA
Date Received: 06/20/2017 Patient Sequence Number: 1
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