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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
Event Date 11/12/2014
Event Type  Malfunction  
Event Description

It was reported that during initial vns implant surgery on (b)(6) 2014, the generator was connected to the lead and system diagnostic results showed normal device function. The generator was disconnected and the surgeon began creating the generator pocket. The generator was reconnected and placed in the generator pocket; however, subsequent diagnostic results showed a near end of service condition. At the patient¿s follow-up appointment, the patient¿s device showed a pulse disabled message. The physician elected to program on the patient¿s device. Attempts for additional relevant information have been unsuccessful to date.

 
Event Description

Follow-up was received from the patient¿s new neurologist that the patient was referred for replacement as the battery was low. A review of the manufacturer¿s in-house programming history was performed. On the date of implant (b)(6) 2014, systems diagnostics showed the impedance was within normal limits and the battery voltage was 3. 261 volts. Upon a second diagnostics test during implant surgery the generator showed an end-of-service condition, and the battery voltage dropped to 1. 897 volts. On (b)(6) 2016 diagnostics testing showed the voltage had recovered, and impedance values were within normal limits. The battery voltage reached the 25% indicator on diagnostics performed on (b)(6) 2016 with a voltage of 2. 846 volts. It had been reported by the company representative that electrocautery was used near the generator during the implant surgery. Additional relevant information has not been received to-date. No known surgery has occurred to-date.

 
Event Description

Replacement surgery occurred. The explanted device was provided to be discarded by the hospital.

 
Event Description

It was later reported the patient¿s device had reached the intensified follow-up battery status indicator. Diagnostics were reported to be normal.

 
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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 Key4326482
Report Number1644487-2014-03297
Device Sequence Number1
Product CodeLYJ
Report Source Manufacturer
Source Type Health Professional,Company Representative,COMPANY REPRESENTATIVE
Reporter Occupation HEALTH PROFESSIONAL
Type of Report Initial
Report Date 02/06/2018
1 Device Was Involved in the Event
0 PatientS WERE Involved in the Event:
Date FDA Received12/12/2014
Is This An Adverse Event Report? No
Is This A Product Problem Report? Yes
Device Operator HEALTH PROFESSIONAL
Device EXPIRATION Date07/31/2016
Device MODEL Number103
Device LOT Number203093
Was Device Available For Evaluation? No
Is The Reporter A Health Professional? Yes
Was the Report Sent to FDA?
Event Location Other
Date Manufacturer Received01/12/2018
Was Device Evaluated By Manufacturer? Device Not Returned To Manufacturer
Date Device Manufactured08/19/2014
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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