BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PRIMEADVANCED

    MDR report key: 2433512 · Received January 31, 2012

    Report

    Report Number
    3004209178-2012-00653
    Event Type
    Injury
    Date Received
    January 31, 2012
    Report Date
    January 11, 2012
    Manufacturer
    MDT PUERTO RICO OPERATIONS CO
    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

    LEAD MODEL 3998 LOT# V014454 SERIAL# UNK IMPLANTED: 2007-(B)(6) EXPLANTED: UNK; LEAD MODEL 3777-75 LOT# UNK (B)(4) IMPLANTED: 2009-(B)(6) EXPLANTED: UNK; PROGRAMMER MODEL 37743 (B)(4); EXTENSION MODEL 37082-60 (B)(4) IMPLANTED: 2008-(B)(6) EXPLANTED: UNK.

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT LOST THERAPEUTIC EFFECT FROM THE 1X8 LEAD FOLLOWING A CARDIAC CATHETERIZATION. THE TWO 2X4 LEADS WERE OKAY. THERE WAS ALSO SWELLING AND REDNESS AT THE NEUROSTIMULATOR SITE TRACKING THE EXTENSION TO THE LEAD. IMPEDANCES MEASURED AT 0.7 VOLTS WERE AS FOLLOWS: 8/9/10=1400-1600, 11= 5500, 12=7700, 13/14=1400, 15=1200. PAST IMPEDANCE MEASUREMENTS WERE UNAVAILABLE FOR COMPARISON. THE PATIENT WAS PROGRAMMED AT 8- 11+ 12+ 15-; A MANUFACTURER REPRESENTATIVE WAS GOING TO ATTEMPT REPROGRAMMING. ADDITIONAL INFORMATION HAS BEEN REQUESTED BUT WAS NOT AVAILABLE AS OF THE DATE OF THIS REPORT.

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION RECEIVED REPORTED IMPEDANCES WITH ELECTRODES #11, 12, AND 13 WERE ELEVATED IN THE 3000 TO 7000 OHM RANGE. IMPEDANCE MEASUREMENTS GREATER THAN 4000 OHMS WERE ALSO REPORTED. AN X-RAY DID NOT REVEAL ANYTHING REMARKABLE. EXHAUSTIVE REPROGRAMMING HAD BEEN ATTEMPTED BUT THE PATIENT WAS NOT GETTING APPROPRIATE STIMULATION WHERE HE NEEDED IT. THE HIGH IMPEDANCE RESULTS WERE ATTRIBUTED TO A PATIENT FALL. THE SWELLING WAS DUE TO SHINGLES. ADDITIONAL INFORMATION RECEIVED INDICATED THE CAUSE OF THE EVENT WAS "TELEMETRY MIGRATION". A SURGICAL REVISION WAS PERFORMED ON (B)(6)-2012 AND THE DEVICE WAS REPROGRAMMED THE SAME DAY. IT WAS INDICATED THAT THE PATIENT INCURRED A NON-SERIOUS INJURY/ILLNESS. IT WAS UNKNOWN IF THE PATIENT REQUIRED HOSPITALIZATION DUE TO THE EVENT.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention