BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PRIMEADVANCED

    MDR report key: 3233409 · Received July 18, 2013

    Report

    Report Number
    3004209178-2013-11951
    Event Type
    Injury
    Date Received
    July 18, 2013
    Date of Event
    June 23, 2013
    Report Date
    June 24, 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

    PRODUCT ID 3708220 LOT# SERIAL# (B)(4), IMPLANTED: 2011 (B)(6), PRODUCT TYPE EXTENSION PRODUCT ID 3778-60 LOT# SERIAL# (B)(4), IMPLANTED: 2011 (B)(6), PRODUCT TYPE LEAD PRODUCT ID 37092 LOT# 288330001, IMPLANTED: 2011 (B)(6), PRODUCT TYPE ACCESSORY PRODUCT ID 37743 LOT# SERIAL# (B)(4), PRODUCT TYPE PROGRAMMER, PATIENT PRODUCT ID 355531 LOT# N298949, IMPLANTED: 2011 (B)(6), PRODUCT TYPE SCREENING DEVICE PRODUCT ID 3487A-56 LOT# V578923, IMPLANTED: 2011 (B)(6), PRODUCT TYPE LEAD PRODUCT ID 3487A-56 LOT# V578923, IMPLANTED: 2011 (B)(6), PRODUCT TYPE LEAD. (B)(4).

    Additional Manufacturer Narrative · 1

    CORRECTIONS.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT FELL AND HAD PAIN AT THE IMPLANT SITE. THE PATIENT WAS IN THE HOSPITAL AFTER THE FALL. IT WAS STATED THAT THE STIMULATOR ¿MOVED AROUND MORE¿ IN THE PATIENT¿S BACK SINCE THE FALL. THE PATIENT WANTED IT REMOVED AND "DID NOT LIKE IT.¿ IT WAS FURTHER STATED, THE PATIENT WAS COMFORTABLE IN THE HOSPITAL. IMPEDANCES WERE MEASURED AND ALL LEADS WERE WITHIN NORMAL LIMITS. IT WAS INDICATED THE PATIENT¿S PARKINSON¿S DISEASE MADE THEM FALL FREQUENTLY. NINETY PERCENT OF THE PATIENT¿S FALLS WERE BACKWARDS. IT WAS NOTED, THE PATIENT¿S WIFE WAS TO TALK TO THEIR DOCTOR ABOUT A PADDED BACK SUPPORT OR POSSIBLY MOVING THE DEVICE TO THE PATIENT¿S BELLY. THE DEVICE WAS REPROGRAMMED AT THE TIME AS WELL. A FOLLOW UP REPORT WILL BE SENT IF ADDITIONAL INFORMATION IS RECEIVED.

    Description of Event or Problem · 1

    FOLLOW UP INFORMATION REPORTED THAT THE MANUFACTURER'S REPRESENTATIVE MET WITH THE PATIENT AT THE HOSPITAL WHERE AN IMPEDANCE CHECK WAS FOUND TO BE NORMAL AND THAT THE IMPLANTABLE NEUROSTIMULATOR (INS) SYSTEM SEEMED INTACT. IT WAS NOTED THAT THE PATIENT WAS UNRESPONSIVE DURING THE VISIT BUT "SEEMED CALM" WHEN THE INS WAS REPROGRAMMED. IF ADDITIONAL INFORMATION IS RECEIVED, A FOLLOW UP REPORT WILL BE SENT

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    333120 PRIMEADVANCED STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF LGW MEDTRONIC MED REL MEDTRONIC PUERTO RICO 37702

    Patients

    Seq Age Sex Outcome Treatment
    1 00062 YR Hospitalization