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U.S. Department of Health and Human Services

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

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CYBERONICS, INC. PULSE GEN MODEL UNK GENERATOR Back to Search Results
Model Number 106
Device Problem High impedance
Event Date 09/14/2015
Event Type  Malfunction  
Event Description

It was reported that system diagnostics run on the patient's vns device returned high impedance immediately after suturing the incisions of the implant surgery. X-rays were taken and review by the healthcare professionals determined that the lead-pin was not fully inserted into the generator's connector block. X-rays review by the manufacturer found that the generator was in the upper left chest in a normal placement. The filter feed-through wires appeared to be intact. The lead connector-pin was not fully inserted into the generator connector block. The electrodes appeared to be placed in normal arrangement. There was lead behind the generator. No lead breaks or sharp bends were found in the visible parts. The lead wires appeared to be intact at the connector pin. It was reported that the patient underwent surgical intervention one day after the implant for lead-pin re-insertion. Once completed, the impedance of the vns system was found to be normal. No device was explanted.

 
Manufacturer Narrative

(b)(4). The suspect device udi was inadvertently not provided in the initial mdr. Sex of patient; corrected data: the previously submitted mdr inadvertently provided an incorrect patient sex. Model #, lot # and expiration date; corrected data: the previously submitted mdr inadvertently provided the incorrect information for the device.

 
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Brand NamePULSE GEN MODEL UNK
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 Key5136335
Report Number1644487-2015-06055
Device Sequence Number1
Product CodeLYJ
Report Source Manufacturer
Reporter Occupation
Type of Report Followup
Report Date 09/14/2015
1 Device Was Involved in the Event
0 PatientS WERE Involved in the Event:
Date FDA Received10/08/2015
Is This An Adverse Event Report? No
Is This A Product Problem Report? Yes
Device Operator HEALTH PROFESSIONAL
Device EXPIRATION Date03/23/2017
Device MODEL Number106
Device LOT Number4309
Was Device Available For Evaluation? No
Is The Reporter A Health Professional? Yes
Was the Report Sent to FDA?
Event Location Other
Date Manufacturer Received11/02/2015
Was Device Evaluated By Manufacturer? Device Not Returned To Manufacturer
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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