BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SURESCAN

    MDR report key: 4883816 · Received July 1, 2015

    Report

    Report Number
    3004209178-2015-12598
    Event Type
    Injury
    Date Received
    July 1, 2015
    Report Date
    June 12, 2015
    Manufacturer
    MEDTRONIC MED REL MEDTRONIC PUERTO RICO
    Product Code
    LGW
    PMA / PMN Number
    P840001
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MN, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    CONCOMITANT MEDICAL PRODUCTS: PRODUCT ID 97740, SERIAL# (B)(4), PRODUCT TYPE: PROGRAMMER, PATIENT; PRODUCT ID 9 7754, SERIAL# (B)(4), PRODUCT TYPE: RECHARGER; PRODUCT ID 3777-60, SERIAL# (B)(4), IMPLANTED: (B)(6) 2014, PRODUCT TYPE: LEAD; PRODUCT ID 3777-60, SERIAL# (B)(4), IMPLANTED: (B)(6) 2014, PRODUCT TYPE: LEAD. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THE PATIENT HAD PAIN AT THE BATTERY SITE SO THE DEVICE WAS EXPLANTED. THE PATIENT DID NOT LIKE FEELING THE BATTERY WHEN THEY SAT OR LEANED AGAINST IT. THERE WAS NO ISSUE WITH THE DEVICE AND THE PATIENT WAS NON-COMPLIANT AND RARELY USED THE DEVICE. THE PATIENT SCHEDULED A FOLLOW-UP APPOINTMENT FOR (B)(6) 2015.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    425017 SURESCAN STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF LGW MEDTRONIC MED REL MEDTRONIC PUERTO RICO 97713

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention