BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    RESTORE SENSOR

    MDR report key: 3830622 · Received May 23, 2014

    Report

    Report Number
    3004209178-2014-09585
    Event Type
    Malfunction
    Date Received
    May 23, 2014
    Report Date
    February 1, 2014
    Manufacturer
    MEDTRONIC PUERTO RICO OPERATIONS CO.
    Product Code
    LGW
    PMA / PMN Number
    P840001
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MI, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    CONCOMITANT MEDICAL PRODUCTS: PRODUCT ID: 37743, SERIAL# (B)(4), PRODUCT TYPE: PROGRAMMER, PATIENT. PRODUCT ID: 37752, SERIAL# (B)(4), PRODUCT TYPE: RECHARGER. PRODUCT ID: NEU_UNKNOWN_LEAD, SERIAL# UNKNOWN, PRODUCT TYPE: LEAD. PRODUCT ID: NEU_UNKNOWN_LEAD, SERIAL# UNKNOWN, PRODUCT TYPE: LEAD. PRODUCT ID: 37712, SERIAL# (B)(4), IMPLANTED: (B)(6) 2010, PRODUCT TYPE: IMPLANTABLE NEUROSTIMULATOR. PRODUCT ID: 97740, SERIAL# (B)(4), PRODUCT TYPE: PROGRAMMER, PATIENT. PRODUCT ID: 97754, SERIAL# (B)(4), PRODUCT TYPE: RECHARGER. (B)(4).

    Additional Manufacturer Narrative · 1

    CONCOMITANT PRODUCTS: PRODUCT ID: 37743, SERIAL# (B)(4), PRODUCT TYPE: PROGRAMMER, PATIENT. PRODUCT ID: 3 7752, SERIAL# (B)(4), PRODUCT TYPE: RECHARGER. PRODUCT ID: NEU_UNKNOWN_LEAD, PRODUCT TYPE: LEAD. PRODUCT ID: NEU_UNKNOWN_LEAD, PRODUCT TYPE: LEAD. PRODUCT ID: 37712, SERIAL# (B)(4), IMPLANTED: (B)(6) 2010, PRODUCT TYPE: IMPLANTABLE NEUROSTIMULATOR. PRODUCT ID: 97740, SERIAL# (B)(4), PRODUCT TYPE: PROGRAMMER, PATIENT . PRODUCT ID: 97754, SERIAL# (B)(4), PRODUCT TYPE RECHARGER PRODUCT ID: NEU_UNKNOWN_LEAD, PRODUCT TYPE: LEAD. PRODUCT ID: NEU_UNKNOWN_LEAD, PRODUCT TYPE: LEAD. (B)(4).

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION RECEIVED REPORTED THAT THERE WERE NO FRACTURED LEADS. HOWEVER, WHEN ASKED WHICH LEADS HAD THE FRACTURE THE MANUFACTURER REPRESENTATIVE REPLIED THAT THERE WAS ONE ELECTRODE IN THE RIGHT BATTERY AND ONE ELECTRODE IN THE LEFT. IT WAS NOTED THAT TWO OF THE PATIENT'S S 16 ELECTRODES WERE GREATER THAN 10,000 AND THEY REPORTEDLY PROGRAMMED AROUND IT. IT WAS ALSO CONFIRMED THAT AT THE TIME OF THE REPORT THE PATIENT HAD 4 LEADS IMPLANTED. IT WAS FURTHER REPORTED THAT THIS ISSUE WAS NOTICED ON REPROGRAMMING "MONTHS AGO." PLEASE REFER TO MANUFACTURES REPORT # 3004209178-2014-09585 FOR ADDITIONAL INFORMATION ON A RELATED DEVICE.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THERE WERE LEAD FRACTURES, ONE LEAD ON THE RIGHT SIDE AND LEFT SIDE ELECTRODE 6 ON ONE SIDE AND 5 ON THE OTHER. IT WAS UNKNOWN WHICH ELECTRODE WAS FRACTURED ON WHICH SIDE. IT WAS FURTHER REPORTED THAT THE PATIENT HAD ¿SUPER ORBITAL MIGRAINES. TWO OF THE STIMULATORS WITH 4 LEADS 32 ELECTRODES. HIP AND DBS DEVICES. FAILURE OF DEVICES.¿ IT IS UNCLEAR WHAT WAS MEANT BY THIS. INTERNAL MANUFACTURE RECORDS SHOW THAT THE PATIENT DOES NOT HAVE A DEEP BRAIN STIMULATION (DBS) DEVICE. ADDITIONAL INFORMATION REPORTED THAT THE LEAD ISSUES HAD RESOLVED AND WAS NO LONGER AN ISSUE. PLEASE REFER TO MANUFACTURES REPORT # 3004209178-2014-09583 FOR ADDITIONAL INFORMATION ON A RELATED DEVICE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    308739 RESTORE SENSOR STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF LGW MEDTRONIC PUERTO RICO OPERATIONS CO. 37714

    Patients

    Seq Age Sex Outcome Treatment
    1 00063 YR