BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LOW PROFILE EXTENSION

    MDR report key: 1001737 · Received February 19, 2008

    Report

    Report Number
    6000153-2008-00789
    Event Type
    Malfunction
    Date Received
    February 19, 2008
    Date of Event
    January 1, 2008
    Report Date
    January 23, 2008
    Manufacturer
    MEDTRONIC PUERTO RICO OPERATIONS CO
    Product Code
    MHY
    PMA / PMN Number
    P960009
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    THE PHYSICIAN REPORTED THAT THE EXTENSIONS HAD MIGRATED AFTER A REVISION WAS PERFORMED; THE EXTENSIONS HAD BEEN ANCHORED TO THE SKULL DURING THE CASE. THE HCP STATED THE MIGRATION HAD OCCURRED "DESPITE REVISION, WILL REQUIRE RE-POSITIONING OF IPG AND SHORTER EXTENSIONS." NO PT SYMPTOMS HAD BEEN REPORTED; THERE WAS NO PT INJURY. REFER TO MFR REPORTS #6000153200800275 AND 6000153200800788.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 LOW PROFILE EXTENSION MHY MEDTRONIC PUERTO RICO OPERATIONS CO 7482 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 EXPLANTED| IMPLANTED| IMPLANTED| IMPLANTED| LEAD MODEL 3387 LOT#V073564| IMPLANTABLE NEURO STIMULATOR MODEL 7428| IMPLANTED| LEAD MODEL 3387 LOT #V073564| EXPLANTED| LOT# NFD103402H| PROGRAMMER MODEL UNK LOT #UNK| EXPLANTED