BEUDAMED
    FDA Adverse Event Injury Summary report: N

    RESTORE SENSOR

    MDR report key: 10706655 · Received October 20, 2020

    Report

    Report Number
    3004209178-2020-18330
    Event Type
    Injury
    Date Received
    October 20, 2020
    Date of Event
    November 1, 2017
    Report Date
    October 20, 2020
    Manufacturer
    MEDTRONIC PUERTO RICO OPERATIONS CO.
    Product Code
    LGW
    UDI-DI
    00613994610430
    PMA / PMN Number
    P840001
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 1

    CONCOMITANT MEDICAL PRODUCTS: PRODUCT ID: 37791, SERIAL# UNKNOWN, PRODUCT TYPE: RECHARGER. PRODUCT ID: 97754, SERIAL# (B)(4), PRODUCT TYPE: RECHARGER. IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Description of Event or Problem · 1

    INFORMATION WAS RECEIVED FROM A CONSUMER REGARDING A PATIENT IMPLANTED WITH A NEUROSTIMULATOR FOR THE TREATMENT OF NON-MALIGNANT PAIN. IT WAS REPORTED THAT IT WAS TAKING THE PATIENT LONGER TO CHARGE THEIR IMPLANT. THEY NORMALLY KEPT THE IMPLANT CHARGED AT 25%, NEVER ALLOWING IT TO GO BELOW 50%, AND USUALLY CHARGING TO FULL WOULD TAKE 45 MINUTES TO AN HOUR BUT NOW IT WAS TAKING ABOUT 2 HOURS TO CHARGE TO FULL. IT WAS REVIEWED WITH THE PATIENT HOW PROGRAMMED PARAMETERS AFFECT THE RECHARGE INTERVAL. PER THE PATIENT THEY DIDN'T HAVE ANY PARAMETER CHANGES. IT WAS ALSO REVIEWED HOW THE NUMBER OF EFFICIENCY BARS AFFECT RECHARGE TIME. IT WAS ALSO NOTED THAT THEY STARTED GETTING POOR COUPLING AROUND THE SAME TIME THEY NOTICED IT WAS TAKING LONGER TO CHARGE. THEY WERE ABLE TO GET TO 8 BARS EVENTUALLY BUT THEY HAD A TERRIBLE TIME DOING IT. A REPLACEMENT RECHARGER ANTENNA WAS SENT AND THE PATIENT WAS ADVISED TO CONTACT THEIR HEALTH CARE PROVIDER IF THE ISSUE DID NOT RESOLVE. ADDITIONAL INFORMATION WAS RECEIVED REPORTING THAT AFTER THE REPLACEMENT OF THE ANTENNA THE SAME ISSUE PERSISTED. THE PATIENT NOTED THEY "SAT ON IT" THE NIGHT PRIOR FOR 2.5 HOURS AND 45 MINUTES WITH 8 THEN 6 COUPLING BARS FILLED AND IT NEVER FULLY CHARGED. IT WAS NOTED THE BATTERY LEVEL WAS HALF TO A QUARTER FROM FULLY CHARGED AT THE START OF THE RECHARGE SESSION, AND THE CHARGING USED TO TAKE 1 HOUR FOR THEM. A REPLACEMENT RECHARGER WAS SENT. THE PATIENT REPORTED THAT SHE HAD THE SYSTEM REMOVED BECAUSE SHE WAS HAVING SO MUCH PROBLEMS WITH IT. SHE HAD TO SIT 2-3 HOURS A DAY TO RECHARGE IT AND IT DID NOT HELP HER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1171844 RESTORE SENSOR STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF LGW MEDTRONIC PUERTO RICO OPERATIONS CO. 37714 00613994610430

    Patients

    Seq Age Sex Outcome Treatment
    1 71 YR Required Intervention