BEUDAMED
    FDA Adverse Event Injury Summary report: N

    RESTORE

    MDR report key: 4480855 · Received February 3, 2015

    Report

    Report Number
    3004209178-2015-01676
    Event Type
    Injury
    Date Received
    February 3, 2015
    Report Date
    January 14, 2015
    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
    TN, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    CONCOMITANT MEDICAL PRODUCTS: PRODUCT ID: 37083-60, SERIAL# (B)(4), IMPLANTED: (B)(6) 2009, PRODUCT TYPE: EXTENSION. PRODUCT ID: 37083-60, SERIAL# (B)(4), IMPLANTED: (B)(6) 2009, PRODUCT TYPE: EXTENSION. PRODUCT ID: 3587A25, LOT# N165959, IMPLANTED: (B)(6) 2009, PRODUCT TYPE: LEAD. PRODUCT ID: 3587A25, LOT# N161298, IMPLANTED: (B)(6) 2009, PRODUCT TYPE: LEAD. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT HAD TWO STIMULATORS BUT THE MOST RECENT ONE THAT WAS IMPLANTED ON (B)(6) 2012 ON THE RIGHT SIDE WAS REMOVED. THE PATIENT HAD ISSUES IN THE PAST WITH SURGERIES AND STAPH INFECTIONS WHEN A DOCTOR WAS INSTALLING AND MANAGING. THE PATIENT WAS THEN REFERRED TO A DIFFERENT DOCTOR FOR CONSULTATION TO RE-IMPLANT THE RIGHT STIMULATOR JUST LAST YEAR, ABOUT 4 MONTHS AGO, BUT SHE DID NOT GET AN IMPLANT YET. THE REASON WHY IT WAS REMOVED WAS BECAUSE THE PATIENT WAS HAVING PAIN ON THAT SIDE WHERE THE INS WAS LOCATED AND THEN WHEN THE HEALTHCARE PROVIDER (HCP) TOOK IT OUT THEY SAID IT WAS A DEFECTIVE BATTERY. IT WAS NOTED THAT SHE WAS STILL CHARGING THE BATTERY PRIOR TO IT BEING REMOVED. THE HCP DECIDED NOT TO RE-IMPLANT ANOTHER ONE ON THE RIGHT SIDE BECAUSE OF INFECTION. THE PATIENT COULD NOT REMEMBER WHEN THE INFECTION STARTED OR WHEN THE INS WAS TAKEN OUT. NO OUTCOME WAS REPORTED REGARDING THIS EVENT. FURTHER FOLLOW-UP IS BEING CONDUCTED TO OBTAIN THIS INFORMATION. IF ADDITIONAL INFORMATION IS RECEIVED, A FOLLOW-UP REPORT WILL BE SENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    78478 RESTORE STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF LGW MEDTRONIC MED REL MEDTRONIC PUERTO RICO 37711

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention