BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PRIMEADVANCED

    MDR report key: 2992081 · Received March 7, 2013

    Report

    Report Number
    3004209178-2013-03420
    Event Type
    Injury
    Date Received
    March 7, 2013
    Report Date
    February 14, 2013
    Manufacturer
    MEDTRONIC MED REL MEDTRONIC PUERTO RICO
    Product Code
    LGW
    PMA / PMN Number
    P840001
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MN, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Additional Manufacturer Narrative · 1

    PRODUCT ID, 39286-65 LOT# SERIAL# (B)(4), IMPLANTED: 2010 (B)(6), PRODUCT TYPE LEAD PRODUCT ID, 3777-60 LOT# SERIAL# (B)(4), IMPLANTED: 2010 (B)(6), PRODUCT TYPE LEAD PRODUCT ID, 3777-60 LOT# SERIAL# (B)(4), IMPLANTED: 2010 (B)(6), PRODUCT TYPE LEAD PRODUCT ID, 37743 LOT# SERIAL# (B)(4), PRODUCT TYPE PROGRAMMER, PATIENT PRODUCT ID, 3708140 LOT# SERIAL# (B)(4), IMPLANTED: 2010 (B)(6), PRODUCT TYPE EXTENSION PRODUCT ID, 3708140 LOT# SERIAL# (B)(4), IMPLANTED: 2010 (B)(6), PRODUCT TYPE EXTENSION. (B)(4).

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION RECEIVED REPORTED THAT THE DEVICE WAS NOT COMPLETELY FLIPPED BUT ROTATED AND "PROTRUDING OUTWARDS". IT WAS SEEN WHEN THE DOCTOR EXAMINED THE PATIENT IN THE EXAM ROOM. THE IMPLANTABLE NEUROSTIMULATORS (INSS) WERE CAUSING HER PAIN BECAUSE THEY WERE NOT LYING FLAT. IT WAS NOTED THAT THERE WAS "NOTHING TECHNICALLY WRONG WITH THE INSS, THEY WERE JUST ROTATED AND CAUSED HER DISCOMFORT". THEY WERE REPLACED AND THE POCKETS WERE REVISED. NO FURTHER INFORMATION WAS PROVIDED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT HAD HER IMPLANTABLE NEUROSTIMULATORS (INSS) "REPLACED DUE TO WEIGHT LOSS." IT WAS FURTHER REPORTED THAT THE PATIENT'S INSS "WERE FLIPPING." IT WAS NOTED THAT THE PATIENT'S CURRENT REPLACEMENT IMPLANTS WERE PLACED "DEEPER." ADDITIONAL INFORMATION HAS BEEN REQUESTED. A SUPPLEMENTAL REPORT WILL BE FILED IF ADDITIONAL INFORMATION IS RECEIVED. PLEASE SEE MFR REPORT # 3004209178-2013-03419 FOR INFORMATION ON THE PATIENT'S OTHER DEVICE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    98003 PRIMEADVANCED STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF LGW MEDTRONIC MED REL MEDTRONIC PUERTO RICO 37702

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention