BEUDAMED
    FDA Adverse Event Injury Summary report: N

    RESTORE SENSOR

    MDR report key: 3950036 · Received July 22, 2014

    Report

    Report Number
    3004209178-2014-13348
    Event Type
    Injury
    Date Received
    July 22, 2014
    Date of Event
    June 14, 2012
    Report Date
    March 30, 2021
    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
    WI, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    CONCOMITANT MEDICAL PRODUCTS: PRODUCT ID: 3778-60, SERIAL# (B)(4), IMPLANTED: (B)(6) 2012, EXPLANTED: (B)(6) 2012, PRODUCT TYPE: LEAD. PRODUCT ID: 37754, SERIAL# (B)(4), PRODUCT TYPE: RECHARGER. PRODUCT ID: 37744, SERIAL# (B)(4), PRODUCT TYPE: PROGRAMMER, PATIENT. PRODUCT ID: 3778-60, SERIAL# (B)(4), IMPLANTED: (B)(6) 2012, EXPLANTED: (B)(6) 2012, PRODUCT TYPE: LEAD. (B)(4).

    Description of Event or Problem · 1

    THE PATIENT¿S IMPLANT WAS REDONE IN (B)(6) OF 2012. THE PATIENT HAS FIBROUS TISSUE, IT WAS REAL POSITIONAL. THE SECOND IMPLANT WAS A SURGICAL LAMINECTOMY, HAD TO SLIDE IT UP 3 LEVELS, DID THAT 3 TIMES. THE SECOND ONE TOOK 3 HOURS AND IT WAS DESCRIBED AS REPOSITIONING, IT WAS CALLED A ¿KEYHOLE PROCEDURE¿. ADDITIONAL INFORMATION HAS BEEN REQUESTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    429142 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 00057 YR Required Intervention