BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SURESCAN

    MDR report key: 9132239 · Received September 27, 2019

    Report

    Report Number
    3004209178-2019-18581
    Event Type
    Malfunction
    Date Received
    September 27, 2019
    Date of Event
    April 15, 2016
    Report Date
    November 8, 2019
    Manufacturer
    MEDTRONIC PUERTO RICO OPERATIONS CO.
    Product Code
    LGW
    UDI-DI
    00643169109490
    PMA / PMN Number
    P840001
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 1

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

    Additional Manufacturer Narrative · 1

    CONCOMITANT MEDICAL PRODUCTS: PRODUCT ID: 3998, LOT#: V041066, IMPLANTED: (B)(6) 2007, PRODUCT TYPE: LEAD. PRODUCT ID: 3708240, SERIAL#: (B)(4), IMPLANTED: (B)(6) 2007, PRODUCT TYPE: EXTENSION. OTHER RELEVANT DEVICE(S) ARE: PRODUCT ID: 3998, SERIAL/LOT #: (B)(4), UBD: 12-JUN-2011, UDI#: (B)(4) ; PRODUCT ID: 3708240, SERIAL/LOT #: (B)(4), UBD: 12-JUN-2011, UDI#: (B)(4). IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION RECEIVED FROM THE HCP INDICATED THAT THEY LAST SAW THE PATIENT ON (B)(6) 2019 FOR A FOLLOW-UP APPOINTMENT AND BELIEVE THAT THE PATIENT HAS HAD NO FURTHER SURGERY SINCE IMPLANT. NO FURTHER COMPLICATIONS WERE REPORTED OR ANTICIPATED.

    Description of Event or Problem · 1

    INFORMATION WAS RECEIVED FROM A CONSUMER WITH AN IMPLANTABLE NEUROSTIMULATOR (INS) FOR SPINAL PAIN. IT WAS REPORTED THAT WHEN THEY PUT THE BATTERY IN, THEY WERE HAVING ISSUES WITH BATTERY CONNECTIONS BECAUSE OF CORROSION. THEY HAD A DIFFICULT TIME GETTING THE WIRES TO CONNECT AND WORK. NO PATIENT SYMPTOMS WERE REPORTED. NO FURTHER COMPLICATIONS WERE REPORTED/ANTICIPATED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    923599 SURESCAN STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF LGW MEDTRONIC PUERTO RICO OPERATIONS CO. 97713 00643169109490

    Patients

    Seq Age Sex Outcome Treatment
    1 41 YR