BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PRIMEADVANCED

    MDR report key: 3352880 · Received September 17, 2013

    Report

    Report Number
    3004209178-2013-16387
    Event Type
    Injury
    Date Received
    September 17, 2013
    Date of Event
    August 22, 2013
    Report Date
    August 22, 2013
    Manufacturer
    MEDTRONIC MED REL MEDTRONIC PUERTO RICO
    Product Code
    LGW
    PMA / PMN Number
    P840001
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MN, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    CONCOMITANT: LEAD 3487A-33, LOT# J0348939V, IMPLANTED: 2003-(B)(6), EXPLANTED: 2013-(B)(6).

    Additional Manufacturer Narrative · 1

    PRODUCT ID 74001; PRODUCT TYPE ADAPTER PRODUCT ID 74001 LOT# N397425, IMPLANTED: 2013 (B)(6); PRODUCT TYPE ADAPTER PRODUCT ID 748925 LOT# SERIAL# (B)(4), IMPLANTED: 2003 (B)(6); PRODUCT TYPE EXTENSION PRODUCT ID 3487A-33 LOT# J0348939V, IMPLANTED: 2003 (B)(6); PRODUCT TYPE LEAD. (B)(4).

    Description of Event or Problem · 1

    THE LEAD WAS REPLACED ON (B)(6). THE PATIENT WAS RECEIVING GOOD STIMULATION AND HAVING GOOD PAIN RELIEF. THE LEAD WAS NOT GOING TO BE RETURNED TO THE DEVICE MANUFACTURER.

    Description of Event or Problem · 1

    THE PATIENT EXPERIENCED NO STIMULATION FOLLOWING DEVICE REPLACEMENT SURGERY. THE DEVICE WAS PROGRAMMED TO 60HZ 360PW AND 10.5V WITH ALL SORTS OF ELECTRODES, SINGLE ANODES, CATHODES ON TOP AND BOTTOM OF LEAD AND THE PATIENT CONTINUED TO FEEL NO STIMULATION. MULTIPLE DIFFERENT POSITIONS WERE TRIED WHICH MADE NO DIFFERENCE. THE CURRENT IMPEDANCE MEASUREMENTS WERE NORMAL. THE PATIENT WAS AT THE HOSPITAL GETTING AN X-RAY. THE COMPANY REPRESENTATIVE WAS SCHEDULED TO SEE THE PATIENT IN TWO WEEKS FOR A FOLLOW UP. IT WAS CONFIRMED THAT SURGICAL FOLLOW UP WAS REQUIRED AND WAS SCHEDULED FOR (B)(6) 2013. THE X-RAY WAS OKAY. THE IMPEDANCES WERE WITHIN NORMAL RANGE BUT ON THE HIGHER END OF NORMAL. IT WAS CLARIFIED THAT THE IMPEDANCES WERE IN THE 2,400-5,000OHMS RANGE AFTER REPLACEMENT. SPECIFICALLY 01=2460, 02=4083, 03=5601, 12=2004, 13=3744, 23=2195. THE SURGICAL REVISION WAS GOING TO BE NEEDED TO ASSESS THE LEAD AND EXTENSION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    468290 PRIMEADVANCED STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF LGW MEDTRONIC MED REL MEDTRONIC PUERTO RICO 37702

    Patients

    Seq Age Sex Outcome Treatment
    1 00073 YR Required Intervention