BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PRIMEADVANCED

    MDR report key: 2770893 · Received October 3, 2012

    Report

    Report Number
    3004209178-2012-08850
    Event Type
    Malfunction
    Date Received
    October 3, 2012
    Report Date
    September 7, 2012
    Manufacturer
    MEDTRONIC MED REL MEDTRONIC PUERTO RICO
    Product Code
    LGW
    PMA / PMN Number
    P840001
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MN, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    PRODUCT ID 3778-45, SERIAL# (B)(4), IMPLANTED: (B)(6) 2009, PRODUCT TYPE LEAD; PRODUCT ID 37743, SERIAL# (B)(4), PRODUCT TYPE PROGRAMMER, PATIENT; PRODUCT ID 3550-39, LOT# N213355, IMPLANTED: (B)(6) 2009, EXPLANTED: PRODUCT TYPE ACCESSORY. (B)(4).

    Additional Manufacturer Narrative · 1

    FINAL DEVICE ANALYSIS OF THE NEUROSTIMULATOR REVEALED: NO ANOMALIES FOUND. VISUAL EXAMINATION AND X-RAY REVEALED NO ISSUE WITH PORTS OR CONNECTORS. A KNOWN GOOD LEAD WAS INSERTED INTO BOTH PORTS WITHOUT DIFFICULTY.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING AN IMPLANT THE INS ((B)(4)) WAS PLACED AND WHEN IMPEDANCE TEST WAS DONE THEY HAD 'BAD IMPEDANCES.' THE DOCTOR FIRMLY BELIEVED IT WAS SEATED PROPERLY, AND WANTED TO TRY ANOTHER INS. THE CALLER BELIEVED INITIAL IMPEDANCE READING THAT WERE BAD WERE DUE TO LEAD NOT BEING INSERTED ALL THE WAY, PERHAPS SETSCREWS WERE TIGHTENED TOO FAR FROM MANUFACTURING. NO INSTRUMENTS REPORTED TO BE USED AROUND NEUROSTIMULATOR. THE PATIENT REPORTED TO GET GOOD STIMULATION AND IMPEDANCE READING IN RECOVERY WITH THE SECOND INS. ACTIVE ELECTRODES FOR PATIENT WERE 0 AND 8.

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION RECEIVED REPORTED THAT THE ORIGINAL DEVICE WAS BEING REPLACED FOR NORMAL BATTERY DEPLETION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PRIMEADVANCED STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF LGW MEDTRONIC MED REL MEDTRONIC PUERTO RICO 37702

    Patients

    Seq Age Sex Outcome Treatment
    1