BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SURESCAN

    MDR report key: 3870138 · Received June 12, 2014

    Report

    Report Number
    3004209178-2014-11500
    Event Type
    Malfunction
    Date Received
    June 12, 2014
    Report Date
    June 4, 2014
    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

    CONCOMITANT MEDICAL PRODUCTS: PRODUCT ID 97754, SERIAL# (B)(4), PRODUCT TYPE: RECHARGER; PRODUCT ID 97740, SERIAL# (B)(4), PRODUCT TYPE: PROGRAMMER, PATIENT; PRODUCT ID 977A260, SERIAL# (B)(4), IMPLANTED: (B)(6) 2014, PRODUCT TYPE: LEAD; PRODUCT ID 977A260, SERIAL# (B)(4), IMPLANTED: (B)(6) 2014, PRODUCT TYPE: LEAD. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A PATIENT¿S IMPLANTABLE NEUROSTIMULATOR (INS) "HAS BEEN GOING CRAZY BY ITSELF." THE PATIENT STATED SHE WAS AT (B)(6) AND "IT STARTED REALLY STRONG DOWN THE LEG." IT WAS STATED SHE WAS WAITING FOR A PRESCRIPTION. IT WAS STATED THAT WHEN SHE LEFT HER INS WAS AT "140" AND WHEN SHE GOT BACK SHE CHECKED IT AND IT WAS AT "240." THE PATIENT STATED IT TURNED UP ON ITS OWN. IT WAS NOTED THAT THE PATIENT WAS CURRENTLY SET AT 80. IT WAS NOTED THAT THE PATIENT ASKED ABOUT A MANUFACTURER¿S REPRESENTATIVE BEING PRESENT AT HER APPOINTMENT TOMORROW OR FRIDAY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    348373 SURESCAN STIMULATOR, SPINAL-CORD, IMPLANTED (PAIN RELIEF) LGW MEDTRONIC MED REL MEDTRONIC PUERTO RICO 97714

    Patients

    Seq Age Sex Outcome Treatment
    1 00055 YR