BEUDAMED
    FDA Adverse Event Injury Summary report: N

    RESTORE ADVANCED

    MDR report key: 3111013 · Received May 14, 2013

    Report

    Report Number
    3004209178-2013-07606
    Event Type
    Injury
    Date Received
    May 14, 2013
    Report Date
    April 26, 2013
    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
    MN, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Additional Manufacturer Narrative · 1

    CONCOMITANT MEDICAL PRODUCTS: PRODUCT ID 3550-39. PRODUCT TYPE: ACCESSORY: PRODUCT ID 3708260, SERIAL# (B)(4), IMPLANTED: (B)(6) 2007. PRODUCT TYPE: EXTENSION: PRODUCT ID 3998, LOT# V017182, IMPLANTED: (B)(6) 2007. PRODUCT TYPE: LEAD: PRODUCT ID 3708260, SERIAL# (B)(4), IMPLANTED: (B)(6) 2007. PRODUCT TYPE: EXTENSION: PRODUCT ID 37742, SERIAL# (B)(4), IMPLANTED: (B)(6) 2007. PRODUCT TYPE: PROGRAMMER, PATIENT: PRODUCT ID 37752, SERIAL# (B)(4), IMPLANTED: (B)(6) 2007. PRODUCT TYPE: RECHARGER: PRODUCT ID 3998, LOT# V019145, IMPLANTED: (B)(6) 2007. PRODUCT TYPE: LEAD: PRODUCT ID 3708260, SERIAL# (B)(4), IMPLANTED: (B)(6) 2007. PRODUCT TYPE: EXTENSION: PRODUCT ID 3708260, SERIAL# (B)(4), IMPLANTED: (B)(6) 2007. PRODUCT TYPE: EXTENSION. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THE PATIENT HAD AN EXPLANT OF THEIR DEVICE SYSTEM AS THE PATIENT NEEDED AN MRI. ADDITIONAL INFORMATION RECEIVED REPORTED THE HEALTH CARE PROVIDER WAS HAVING AN ISSUE REMOVING THE EXTENSION AND TITAN ANCHOR. IT WAS FURTHER REPORTED THE EXTENSION PLASTIC WAS COMING OFF AND SEPARATING FROM THE WIRES. THE REPORTER STATED THAT THEY DID NOT BELIEVE THE EXTENSION HAD BEEN SUTURED DOWN IN THE PLACE WHERE THEY WERE HAVING DIFFICULTIES REMOVING THE DEVICE. IT WAS LATER REPORTED THE CAUSE OF THE ISSUE HAD NOT BEEN DETERMINED. THE EXTENSION AND ANCHOR WERE SUCCESSFULLY EXPLANTED. ADDITIONAL INFORMATION HAS BEEN REQUESTED, BUT WAS NOT AVAILABLE AS OF THE DATE OF THIS REPORT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    212317 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