BEUDAMED
    FDA Adverse Event Injury Summary report: N

    RESTORE ULTRA

    MDR report key: 2973157 · Received February 21, 2013

    Report

    Report Number
    3004209178-2013-02971
    Event Type
    Injury
    Date Received
    February 21, 2013
    Report Date
    February 7, 2013
    Manufacturer
    MEDTRONIC MED REL MEDTRONIC PUERTO RICO
    Product Code
    LGW
    PMA / PMN Number
    P840001
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TN, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    PRODUCT ID, 3777-45 LOT# SERIAL# (B)(4), IMPLANTED: 2012 (B)(6), PRODUCT TYPE LEAD; PRODUCT ID, 3777-45 LOT# SERIAL# (B)(4), IMPLANTED: 2012 (B)(6), PRODUCT TYPE LEAD; PRODUCT ID, 37754 LOT# SERIAL# (B)(4), PRODUCT TYPE RECHARGER; PRODUCT ID, 37744 LOT# SERIAL# (B)(4), PRODUCT TYPE PROGRAMMER, PATIENT; PRODUCT ID, 355024 LOT# N331866, IMPLANTED: 2012 (B)(6), PRODUCT TYPE ACCESSORY. (B)(4).

    Additional Manufacturer Narrative · 1

    (B)(4).

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED, THE PATIENT HAD A REVISION ON 2012 (B)(6) IN WHICH THE PATIENT DID NOT KNOW WHAT WAS DONE BUT "WANTED TO KNOW." IT WAS STATED, THE PATIENT'S PHYSICIAN "MANGLED AND DISFIGURED" HER AND THE PATIENT HAS SCAR TISSUE BUILD UP FROM THE PATIENT'S REVISIONS (REFER TO MANUFACTURER REPORT # 3004209178-2013-02968 AND 3004209178-2013-02969). IT WAS STATED, THE PATIENT HAD A DEVICE PUT IN THE PATIENT'S LEFT SIDE THE DATE OF REVISION. IT WAS NOTED, THE PATIENT HAD SEVERAL REPROGRAMMING DONE THAT WOULD "ONLY HELP FOR A SHORT TIME" AS WELL AS THE PATIENT HAD HAD SEVERAL INJECTIONS THAT HAD DONE THE PATIENT NO GOOD. IT WAS UNCLEAR IF THESE INJECTIONS RELATED TO THE REVISION OR OCCURRED AFTER. ADDITIONAL INFORMATION HAS BEEN REQUESTED, BUT WAS NOT AVAILABLE AS OF THE DATE OF THIS REPORT.

    Description of Event or Problem · 1

    IT WAS FURTHER REPORTED THAT THE PATIENT WAS UNHAPPY WITH THEIR STIMULATOR BUT HUNG UP BEFORE HELP COULD BE OFFERED. IT WAS NOTED THAT THE PATIENT'S STIMULATOR WAS "NOT WORKING". IT WAS NOTED THAT THE PATIENT WANTED THE DEVICE OUT IF THEY COULDN'T GET SUPPORT FOR THEIR SYSTEM. IT WAS FURTHER REPORTED THAT THE PATIENT HAD AN APPOINTMENT TO MEET WITH A MANUFACTURER REPRESENTATIVE AT THEIR DOCTOR'S OFFICE BUT COULDN'T REMEMBER THE TIME OR THE NAME OF THEIR DOCTOR OR THE REPRESENTATIVE. IT WAS NOTED THAT THE PATIENT WAS UPSET AND HAD CONSIDERED HIRING A LAWYER BUT AT THE TIME OF THE REPORT HAD NOT REACHED OUT TO ONE.

    Description of Event or Problem · 1

    IT WAS FURTHER REPORTED THAT THE PATIENT'S LEAD WAS TAKEN OUT (B)(6) 2012. THE PATIENT HAD BEEN DISCHARGED FROM HER PHYSICIANS CARE. IT WAS ALSO STATED THAT THE PATIENT HAS HAD 4 SURGERIES TO REPAIR/REVISE DEVICES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    75493 RESTORE ULTRA STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF LGW MEDTRONIC MED REL MEDTRONIC PUERTO RICO 37712

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention