BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    RESTORE ULTRA

    MDR report key: 3909417 · Received July 2, 2014

    Report

    Report Number
    3004209178-2014-12427
    Event Type
    Malfunction
    Date Received
    July 2, 2014
    Report Date
    June 12, 2014
    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
    MS, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    PRODUCT ID 37743, SERIAL# (B)(4), IMPLANTED: 2008 (B)(6); PRODUCT TYPE PROGRAMMER, PATIENT PRODUCT ID 3777-60, SERIAL# (B)(4), IMPLANTED: 2008 (B)(6); PRODUCT TYPE LEAD PRODUCT ID 3550-29, LOT# N141220, IMPLANTED: 2008 (B)(6); PRODUCT TYPE ACCESSORY. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED, THE IMPLANTABLE NEUROSTIMULATOR (INS) WAS NOT HOLDING A CHARGE FOR AS LONG AS IT USED TO. IT WAS NOTED THAT IMPEDANCE TESTING AND REPROGRAMMING WAS DONE. IT WAS FURTHER NOTED, THE PATIENT AND THEIR HEALTHCARE PROFESSIONAL (HCP) WERE CONSIDERING A REVISION/REPLACEMENT. THE REPORTER STATED, THE PATIENT HAD GOOD COVERAGE WITH THEIR STIMULATION, BUT THEY WERE UNHAPPY WITH THE DIMINISHED TIME THE INS WOULD LAST UNTIL THEY HAD TO RECHARGE. IT WAS NOTED THAT THERE WERE NO PATIENT SYMPTOMS OR COMPLICATIONS ASSOCIATED WITH THIS EVENT. IT WAS FURTHER NOTED, THE PATIENT STATUS AT THE TIME OF THIS REPORT WAS ALIVE WITH NO INJURY. ADDITIONAL INFORMATION RECEIVED REPORTED THAT THERE WAS NOT A 50% OR GREATER SYMPTOM REDUCTION. IT WAS NOTED, THE INS WAS INTERROGATED ON 2014 (B)(6). IT WAS FURTHER NOTED, THE CAUSE OF THE EVENT WAS UNKNOWN. THE REPORTER STATED, THE PATIENT OUTCOME WAS UNKNOWN. ADDITIONAL INFORMATION WAS REQUESTED, BUT WAS NOT AVAILABLE AS OF THE DATE OF THIS REPORT.

    Description of Event or Problem · 1

    IT WAS FURTHER REPORTED THAT THE PHYSICIAN TOLD THE PATIENT TO LET THEM KNOW IF THEY WANTED THEIR STIMULATOR REPLACED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    388141 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