BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    RESTORE SENSOR

    MDR report key: 3811426 · Received May 15, 2014

    Report

    Report Number
    3004209178-2014-08990
    Event Type
    Malfunction
    Date Received
    May 15, 2014
    Report Date
    October 14, 2016
    Manufacturer
    MEDTRONIC MED REL MEDTRONIC PUERTO RICO
    Product Code
    LGW
    PMA / PMN Number
    P840001
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MN, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    CONCOMITANT MEDICAL PRODUCTS: 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. PRODUCT ID: 37754, SERIAL# (B)(4), PRODUCT TYPE: RECHARGER. PRODUCT ID: 37744, SERIAL# (B)(4), PRODUCT TYPE: PROGRAMMER, PATIENT. (B)(4).

    Additional Manufacturer Narrative · 1

    THE IMPLANT DATE (B)(6) 2014 DOES NOT APPLY. THE DEVICE CODE OF (B)(4) DOES NOT APPLY. THE CONCLUSION CODE NO LONGER APPLIES.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THERE WAS A DEVICE IMPLANTED AFTER THE UBD (USE BY DATE). IT WAS NOTED THAT A COPY OF THE IMPLANTED DAILY EXPIRED REPORT FROM (B)(6) 2014 CONTAINED ONE EXPIRED ITEM. THE REPORT INDICATED THAT AN IMPLANTABLE NEUROSTIMULATOR (INS) MODEL 37714 WAS IMPLANTED ON (B)(6) 2014, 282 DAYS PAST THE UBD ((B)(6)2013).

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION WAS RECEIVED FROM THE MANUFACTURER REPRESENTATIVE ON (B)(6) 2014 REPORTING THAT THE INCORRECT IMPLANT DATE WAS SUBMITTED. THE DATE WAS CORRECTED FROM (B)(6) 2014 TO (B)(6) 2012.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    290022 RESTORE SENSOR STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF LGW MEDTRONIC MED REL MEDTRONIC PUERTO RICO 37714

    Patients

    Seq Age Sex Outcome Treatment
    1 00059 YR