BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ITREL 3

    MDR report key: 2478687 · Received March 5, 2012

    Report

    Report Number
    3004209178-2012-01373
    Event Type
    Injury
    Date Received
    March 5, 2012
    Date of Event
    February 10, 2012
    Report Date
    February 10, 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

    NEUROSTIMULATOR MODEL # 37701, SERIAL # (B)(4), IMPLANTED 2009 (B)(6), EXPLANTED UNKNOWN; LEAD MODEL # 3587A, LOT # LC4496, IMPLANTED 2004 (B)(6), EXPLANTED UNKNOWN; EXTENSION MODEL # 748951, LOT # NHU074877V, IMPLANTED 2004 (B)(6), EXPLANTED UNKNOWN; PROGRAMMER MODEL # 7434A, LOT # NGL021989P; LEAD MODEL # 377775, LOT # V002531, IMPLANTED 2006 (B)(6), EXPLANTED UNKNOWN; LEAD MODEL # 377775, LOT # J0555268V, IMPLANTED 2006 (B)(6), EXPLANTED UNKNOWN; PROGRAMMER MODEL # 37742, LOT # NJD015924N.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE MANUFACTURER'S REPRESENTATIVE WAS ASKED TO SEE THE PATIENT IN THE HOSPITAL ON 2012 (B)(6). THE PATIENT HAD BEEN ADMITTED FOR PAIN CONTROL FOR LOW BACK PAIN WHICH WAS OUT OF CONTROL. THE PATIENT HAD A 7425 ITREL STIMULATOR THAT WAS REPLACED IN 2004 FOR LEFT-LEG PAIN, AND A 37701 STIMULATOR THAT WAS PLACED CERVICALLY IN 2009 FOR ARM, SHOULDER AND NECK PAIN. THE PATIENT DID NOT HAVE A STIMULATOR THAT WAS PLACED SPECIFICALLY FOR PAIN CONTROL IN THE LUMBAR REGION, WHERE SHE WAS NOW EXPERIENCING PAIN. THE PHYSICIAN WANTED THE MANUFACTURER'S REPRESENTATIVE TO"CHECK" HER STIMULATORS TO SEE IF THEY WERE "OPERATING NORMALLY". EACH IPG WAS READ WITH A 8840, AND BOTH WERE OPERATING AND ALL CONTACTS WERE WITH IN APPROPRIATE OHM RANGES. IT WAS NOTED THAT THE PATIENT "GOT SICK" OVER A WEEK AGO AND "THREW UP". WHEN SHE "THREW UP", SHE FELT A "POP" IN HER BACK AND HAD HAD UNCONTROLLED PAIN IN HER "LOW BACK" SINCE THAT INCIDENT. THE PATIENT WAS ON A MORPHINE PCA AT THE TIME OF THE EVALUATION. THE MANUFACTURER'S REPRESENTATIVE HAD NOT HEARD ANYTHING FURTHER SINCE THIS TIME AND NO INTERVENTIONS REGARDING THE STIMULATORS WAS PLANNED TO THE BEST OF THIS REPORTER'S KNOWLEDGE. IF ADDITIONAL INFORMATION IS RECEIVED, A FOLLOW UP REPORT WILL BE SENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ITREL 3 STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF LGW MDT PUERTO RICO OPERATIONS CO 7425

    Patients

    Seq Age Sex Outcome Treatment
    1 49 YR Hospitalization