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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: CYBERONICS - HOUSTON PULSE GEN MODEL 103 GENERATOR

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CYBERONICS - HOUSTON PULSE GEN MODEL 103 GENERATOR Back to Search Results
Model Number 103
Device Problem Adverse Event Without Identified Device or Use Problem
Event Date 07/11/2018
Event Type  Injury  
Event Description

It was reported that during the patient's generator replacement surgery, following the removal of the old device and implant of the new device, the new device was interrogated and diagnostics were performed, which were ok. The device was then turned back on to the previous device¿s settings. After programming was complete, the patient experienced heart block. The anesthesiologist monitored the patient and when the generator cycled again, and the patient again experienced heart block. The timeline of this was confirmed by the anesthesiologist who reviewed the cardiac monitor after the completion of the case. The surgeon turned the generator off and the anesthesiologist monitored the patient¿s heart rate for approximately 5 - 10 minutes. No abnormalities were observed during this time period. The device was turned back on, but at a lower output current of 1. 00ma for normal and magnet mode. After turning the device back on at this lower current, her heart rate was monitored for approximately 10 minutes, again no abnormalities were observed and the surgeon contacted the patient¿s neurologist office and they collectively decided to leave the device at the lower output current. No other relevant information has been received to date.

 
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Brand NamePULSE GEN MODEL 103
Type of DeviceGENERATOR
Manufacturer (Section D)
CYBERONICS - HOUSTON
100 cyberonics blvd
houston TX 77058
Manufacturer (Section G)
CYBERONICS - HOUSTON
100 cyberonics blvd
suite 600
houston TX 77058
Manufacturer Contact
njemile crawley
100 cyberonics blvd
suite 600
houston , TX 77058
2812287200
MDR Report Key7738864
Report Number1644487-2018-01316
Device Sequence Number1
Product CodeLYJ
Report Source Manufacturer
Source Type COMPANY REPRESENTATIVE,HEALTH
Reporter Occupation
Type of Report Initial
Report Date 08/01/2018
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received08/01/2018
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? No
Device Operator HEALTH PROFESSIONAL
Device MODEL Number103
Device LOT Number5550
Was Device Available For Evaluation? No
Is The Reporter A Health Professional? Yes
Was the Report Sent to FDA?
Event Location Other
Date Manufacturer Received07/11/2018
Was Device Evaluated By Manufacturer? Device Not Returned To Manufacturer
Date Device Manufactured02/12/2017
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: 08/01/2018 Patient Sequence Number: 1
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