BEUDAMED
    FDA Adverse Event Injury Summary report: N

    RESTORE ADVANCED

    MDR report key: 3042267 · Received April 9, 2013

    Report

    Report Number
    3004209178-2013-04906
    Event Type
    Injury
    Date Received
    April 9, 2013
    Report Date
    March 22, 2013
    Manufacturer
    MEDTRONIC MED REL MEDTRONIC PUERTO RICO
    Product Code
    LGW
    PMA / PMN Number
    P840001
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NE, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    CONCOMITANT MEDICAL DEVICES: PRODUCT ID: 37743, SERIAL#: (B)(4), PRODUCT TYPE: PROGRAMMER, PATIENT; PRODUCT ID: 3888-33, LOT#: V362201, IMPLANTED: (B)(6) 2009, PRODUCT TYPE: LEAD; PRODUCT ID: 3998, LOT#: J0511626V, IMPLANTED: (B)(6) 2005, PRODUCT TYPE: LEAD; PRODUCT ID: 3888-33, LOT#: V362201, IMPLANTED: (B)(6) 2009, PRODUCT TYPE: LEAD; PRODUCT ID: 37752, SERIAL#: (B)(4), PRODUCT TYPE: RECHARGER; PRODUCT ID: 3708240, SERIAL#: (B)(4), IMPLANTED: (B)(6) 2009, PRODUCT TYPE: EXTENSION; PRODUCT ID: 748951, SERIAL#: (B)(4), IMPLANTED: (B)(6) 2005, PRODUCT TYPE: EXTENSION; PRODUCT ID: 748951, SERIAL#: (B)(4), IMPLANTED: (B)(6) 2005, PRODUCT TYPE: EXTENSION. (B)(4).

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT FOR THE 3 MONTHS PRIOR TO REPORT THE IMPLANTABLE NEUROSTIMULATOR (INS) HAD BEEN "CUTTING INTO" THE PATIENT'S BACK AND WAS "KIND OF INFECTED". THE PATIENT SAW HIS HEALTHCARE PROVIDER AND RECEIVED ANTIBIOTICS. IT WAS REPORTED THE INFECTION HAD CLEARED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    147253 RESTORE ADVANCED STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF LGW MEDTRONIC MED REL MEDTRONIC PUERTO RICO 37713

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention