BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TRANSFORM

    MDR report key: 7415543 · Received April 10, 2018

    Report

    Report Number
    2182208-2018-00466
    Event Type
    Injury
    Date Received
    April 10, 2018
    Date of Event
    February 27, 2018
    Report Date
    April 10, 2018
    Manufacturer
    MEDTRONIC, INC.
    Product Code
    LDK
    PMA / PMN Number
    G860225
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OR, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE IMPLANTABLE PULSE GENERATOR (IPG) SYSTEM WAS EXPLANTED DUE TO INFECTION. THE DEVICE ERODED FROM THE POCKET AND WAS VISIBLE AT A BREAK IN THE SKIN. CULTURES WERE TAKEN. ANTIBIOTIC TREATMENT WAS NECESSARY. NO FURTHER PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    253479 TRANSFORM LDK MEDTRONIC, INC. 4710

    Patients

    Seq Age Sex Outcome Treatment
    1 71 YR Hospitalization| R