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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: CYBERONICS, INC. PULSE GEN MODEL 106 GENERATOR

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CYBERONICS, INC. PULSE GEN MODEL 106 GENERATOR Back to Search Results
Model Number 106
Device Problems Fracture; High impedance
Event Date 07/30/2015
Event Type  Malfunction  
Event Description

It was reported that high impedance was observed 15 days following generator replacement. X-rays were taken and sent to manufacturer for review. Review of x-rays were unable to determine whether or not the lead pin was fully inserted into the generator header due to the angle of the images. There were no obvious discontinuities in the portion of the lead that could be seen. The presence of a micro-fracture in the lead also cannot be ruled out. It was reported that the patient was seen by the surgeon at which time high impedance was again confirmed. The patient was scheduled for revision surgery. It was reported that the lead pin would be reinserted into the generator header; however, if this does not resolve the high impedance then lead revision would be performed. No known surgical interventions have been performed to date.

 
Manufacturer Narrative

(b)(4).

 
Event Description

It was reported that during the surgery the lead pin was reinserted into the generator header which resolved the high impedance. The cause of the high impedance was a lead/generator connection issue.

 
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Brand NamePULSE GEN MODEL 106
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 Key5025253
Report Number1644487-2015-05597
Device Sequence Number1
Product CodeLYJ
Report Source Manufacturer
Reporter Occupation
Type of Report Followup
Report Date 07/30/2015
1 Device Was Involved in the Event
0 PatientS WERE Involved in the Event:
Date FDA Received08/24/2015
Is This An Adverse Event Report? No
Is This A Product Problem Report? Yes
Device Operator LAY USER/PATIENT
Device EXPIRATION Date06/23/2017
Device MODEL Number106
Device LOT Number2163
Was Device Available For Evaluation? No
Is The Reporter A Health Professional? Yes
Was the Report Sent to FDA?
Event Location Other
Date Manufacturer Received09/01/2015
Was Device Evaluated By Manufacturer? Device Not Returned To Manufacturer
Date Device Manufactured07/09/2015
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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