BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SURESCAN

    MDR report key: 4090327 · Received September 15, 2014

    Report

    Report Number
    3004209178-2014-17047
    Event Type
    Injury
    Date Received
    September 15, 2014
    Report Date
    August 16, 2014
    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: 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) 2013, EXPLANTED: (B)(6) 2014, PRODUCT TYPE: LEAD. PRODUCT ID: 977A260, SERIAL# (B)(4), IMPLANTED: (B)(6) 2013, EXPLANTED: (B)(6) 2014, PRODUCT TYPE: LEAD. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED AFTER ONE FULL YEAR OF TRIAL AND ADJUSTMENTS THEY HAD STILL NOT ACHIEVED THE 70%+ REDUCTION IN PAIN ACHIEVED IN THE INITIAL EXTERNAL TRIAL WITH ¿(B)(6)¿ MADE SENSORS NOT APPROVED BY THE FDA FOR IMPLANT. THE PATIENT WOULD ONLY GET LOWER BUTTOCKS SIGNAL/RELIEF WHEN THEY NEEDED IT THE MOST AT THEIR MID TO LOWER BACK. TWO WEEKS PRIOR TO REPORT, THE PATIENT WENT THROUGH A LEAD REVISION. ADDITIONAL INFORMATION RECEIVED REPORTED THEY REVISED THE LEADS WHERE THEY DETERMINED THE IMPEDANCES WERE OKAY FOR THE NEW LEADS. THE PATIENT HAD STATED THEY WERE NOT GETTING GOOD RELIEF AND THAT IS WHY THE LEADS WERE REPLACED. THERE WAS NOTHING WRONG WITH THE OLD LEADS OR THE DEVICE AT THAT TIME. THE EXPLANTED LEADS WERE DISCARDED AND THE PATIENT STATUS WAS THE SAME (NO THERAPY) UNTIL THE REPLACEMENT SURGERY OCCURRED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    568920 SURESCAN STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF LGW MEDTRONIC MED REL MEDTRONIC PUERTO RICO 97712

    Patients

    Seq Age Sex Outcome Treatment
    1 00061 YR Required Intervention