BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INTELLIS

    MDR report key: 11826998 · Received May 14, 2021

    Report

    Report Number
    3004209178-2021-07748
    Event Type
    Malfunction
    Date Received
    May 14, 2021
    Report Date
    May 14, 2021
    Manufacturer
    MEDTRONIC PUERTO RICO OPERATIONS CO.
    Product Code
    LGW
    UDI-DI
    00643169781702
    PMA / PMN Number
    P840001
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Description of Event or Problem · 1

    CALLER STATES THE PT SAID THE SCS IS NOT WORKING, THE BATTERY IS DEPLETED AND "IT IS DISCONNECTED". CALLER WAS UNABLE TO PROVIDE ANY ADDITIONAL CLARIFICATION BUT NOTED THAT THE PT WAS GOING TO HAVE THE SCS REMOVED PRIOR TO THE PANDEMIC. CALLER WAS NOT WITH PT AT TIME OF CALL. NO PATIENT SYMPTOMS REPORTED. ADDITIONAL INFORMATION WAS RECEIVED FROM A CONSUMER. THE REASON FOR CALL WAS PT'S DAUGHTER (CALLER) STATED IN (B)(6) 2019, THE INS STARTED TO NOT CHARGE PROPERLY SO THEY HAD A PROCEDURE SCHEDULED TO EITHER REMOVE OR REPLACE THE INS. HOWEVER CALLER SAID THE PANDEMIC HIT AND THEY CANCELLED THE PROCEDURE SO PT STILL HAD THE INS IMPLANTED. ADDITIONAL INFORMATION RECEIVED. PT CALLED TO GET A HOLD OF A REP. PT SAID HER BATTERY WAS DEAD. REP ALREADY SAW THE PT AND KNOWS THE BATTERY WAS DEAD. REP SPENT THE WHOLE EVENING AND WAS NOTABLE TO JUMP START THE BATTERY. PT DNK THE NAME OF THE REP. REDIRECTED TO HCP. REVIEWED HCP CAN CONTACT NAS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    721620 INTELLIS STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF LGW MEDTRONIC PUERTO RICO OPERATIONS CO. 97715 00643169781702

    Patients

    Seq Age Sex Outcome Treatment
    1