BEUDAMED
    FDA Adverse Event Injury Summary report: N

    RESTORE PRIME ADVANCED

    MDR report key: 2251564 · Received September 14, 2011

    Report

    Report Number
    3007566237-2011-07840
    Event Type
    Injury
    Date Received
    September 14, 2011
    Date of Event
    August 16, 2010
    Report Date
    August 18, 2011
    Manufacturer
    MEDTRONIC NEUROMODULATION
    Product Code
    LGW
    PMA / PMN Number
    P840001
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NL
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT ON (B)(6) 2010, THE PT WAS IMPLANTED WITH AN OCTAD LEAD CONNECTED DIRECTLY TO A PRIME ADVANCED. THE OCTAD LEAD WAS FIXED WITH A TITAN ANCHOR AND THE PRIME ADVANCED WAS PLACED ON THE BACK. THE PT EXPERIENCED CHANGING PARESTHESIA AND X-RAYS WERE TAKEN ON (B)(6) 2010. THE X-RAYS SHOWED LEAD MIGRATION AND A REVISION WAS DONE ON (B)(6) 2011. IT WAS THOUGHT THAT THE LEAD MIGRATION WAS DUE TO PROBLEMS WITH THE TITAN ANCHOR. ADD'L INFO HAS BEEN REQUESTED, BUT WAS NOT AVAILABLE AT THE DATE OF THIS REPORT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 RESTORE PRIME ADVANCED LGW MEDTRONIC NEUROMODULATION 37702 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 55 YR Required Intervention IMPLANTED:| EXPLANTED:| STIM ACCESSORY: MODEL 3550-39, LOT# 0203030072| IMPLANTED:| UNK CONVERSION TYPE: MODEL LEADN, LOT# UNK| EXPLANTED: