BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SURESCAN

    MDR report key: 13256433 · Received January 13, 2022

    Report

    Report Number
    3004209178-2022-00629
    Event Type
    Injury
    Date Received
    January 13, 2022
    Date of Event
    June 1, 2021
    Report Date
    January 13, 2022
    Manufacturer
    MEDTRONIC PUERTO RICO OPERATIONS CO.
    Product Code
    LGW
    UDI-DI
    00643169109483
    PMA / PMN Number
    P840001
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MI, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    CONCOMITANT MEDICAL PRODUTCS: PRODUCT ID: 977A260, SERIAL# (B)(4), IMPLANTED: (B)(6) 2014, PRODUCT TYPE: LEAD. PRODUCT ID: 977A260, SERIAL# (B)(4), IMPLANTED: (B)(6) 2014 PRODUCT TYPE: LEAD. OTHER RELEVANT DEVICE(S) ARE: PRODUCT ID: 977A260, SERIAL/LOT #: (B)(4) UBD: 04-MAR-2018, UDI#: (B)(4). IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Description of Event or Problem · 0

    INFORMATION WAS RECEIVED FROM A PATIENT WHO WAS IMPLANTED WITH AN IMPLANTABLE NEUROSTIMULATOR (INS) FOR UNKNOWN INDICATIONS FOR USE. THE REASON FOR CALL WAS PT STATED IN (B)(6) 2021 THEY GOT REALLY SICK AND WENT TO THE ER AND WAS IN THE ICU FOR 8 DAYS BECAUSE THEIR LEAD GOT PULLED OUT FROM THE SPINE AND PT GOT A STAPH INFECTION. PT SAID THEY HAD TO HAVE ALL OF THEIR EQUIPMENT REMOVED FROM THEIR BODY DUE TO THE INFECTION (PT SAID THIS WAS IN (B)(6)). PT SAID THEY WERE ON A "PUMP" FOR 2 MONTHS AFTERWARDS. PT SAID THEY NOW MOVED TO MICHIGAN AND HAS A NEW HEALTHCARE PROVIDER (HCP)/NEUROLOGIST BUT ONE HCP SAID PT WAS NOT A CANDIDATE FOR SPINAL CORD STIMULATION (SCS). PT SAID THEY DIDN'T KNOW WHY THEY SAID THAT, AND PT SAID THEIR S1 AND L 3,4,5 WERE BULGED AND PT WAS NOT ON PAIN MEDS RIGHT NOW AND WAS ABOUT READY TO GO NUTS SO PT REALLY WANTED ANOTHER SCS. PT MENTIONED THE SCS WAS THEIR LIFELINE SO THEY COULD WALK. PT SAID THEY DID NOT HAVE A REP IN NEW AREA AND ASKED TO GET IN TOUCH WITH ONE. PT SAID THEY HAD AN HCP APPOINTMENT NEXT TUESDAY.  PATIENT SERVICES  EMAILED FYI TO FIELD TEAM IN PT'S AREA. PATIENT SERVICES DOCUMENTING INFORMATION GIVEN DURING THE CALL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    659830 SURESCAN STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR LGW MEDTRONIC PUERTO RICO OPERATIONS CO. 97714 00643169109483

    Patients

    Seq Age Sex Outcome Treatment
    1 62 YR Female Life Threatening| H| R