BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PRIMEADVANCED

    MDR report key: 3173693 · Received June 17, 2013

    Report

    Report Number
    3004209178-2013-10475
    Event Type
    Injury
    Date Received
    June 17, 2013
    Report Date
    May 28, 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
    TX, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    CONCOMITANT MEDICAL PRODUCTS: PRODUCT ID: 3708140, SERIAL# (B)(4), IMPLANTED: (B)(6) 2011, EXPLANTED: (B)(6) 2013, PRODUCT TYPE: EXTENSION. PRODUCT ID: 3708140, SERIAL# (B)(4), IMPLANTED: (B)(6) 2011, EXPLANTED: (B)(6) 2013, PRODUCT TYPE: EXTENSION. PRODUCT ID: 37743, SERIAL# (B)(4), PRODUCT TYPE: PROGRAMMER, PATIENT. PRODUCT ID: 3777-60, SERIAL# (B)(4), IMPLANTED: (B)(6) 2011, EXPLANTED: (B)(6) 2013, PRODUCT TYPE LEAD. PRODUCT ID: 3777-60, SERIAL# (B)(4), IMPLANTED: (B)(6) 2011, EXPLANTED: (B)(6) 2013, PRODUCT TYPE: LEAD. (B)(4).

    Additional Manufacturer Narrative · 1

    CONCOMITANT PRODUCTS: PRODUCT ID 3708140, SERIAL # (B)(4), IMPLANTED: (B)(6) 2011, PRODUCT TYPE EXTENSION; PRODUCT ID 3708140, SERIAL # (B)(4), IMPLANTED: (B)(6) 2011, PRODUCT TYPE EXTENSION; PRODUCT ID 3777-60 SERIAL # (B)(4), IMPLANTED: (B)(6) 2011, PRODUCT TYPE LEAD; PRODUCT ID 37743, SERIAL # (B)(4), PRODUCT TYPE PROGRAMMER, PATIENT; PRODUCT ID 3777-60, SERIAL # (B)(4), IMPLANTED: (B)(6) 2011, PRODUCT TYPE LEAD; PRODUCT ID 3777-60, SERIAL # (B)(4), IMPLANTED: (B)(6) 2011, PRODUCT TYPE LEAD; PRODUCT ID 3777-60, SERIAL # (B)(4), IMPLANTED: (B)(6) 2011, PRODUCT TYPE LEAD. (B)(4).

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION RECEIVED REPORTED THAT SPINAL CORD STIMULATION (SCS) HELPED RELIEVE THE PATIENT'S PAIN INITIALLY, BUT THEN SHE LOST THERAPEUTIC EFFECT. THE EVENT WAS ATTRIBUTED TO "STIMULATION." ON (B)(6) 2013 IT WAS NOTED THAT ELECTRODE IMPEDANCES FOUND ELECTRODES 1-4 (WITH REGARD TO THE FIRST 15) WERE OUT OF RANGE AT GREATER THAN 10,000 OHMS. ON THIS DATE IT WAS ALSO NOTED THE PATIENT INDICATED SHE WAS NOT RECEIVING PARESTHESIA/STIMULATION COVERAGE TO THE NECK AND SHOULDERS. SHE HAD A RETURN OF PAIN IN THE NECK AND SHOULDERS. REPROGRAMMING WAS UNABLE TO OBTAIN COVERAGE IN THE PATIENT'S NECK AND SHOULDERS. IT WAS REPORTED THE PATIENT UNDERWENT A FULL SYSTEM EXPLANT ON (B)(6) 2013, HOSPITALIZATION WAS NOT REQUIRED. THE PATIENT'S PAIN WAS REPORTEDLY BEING MANAGED BY AN ALTERNATIVE THERAPY (NON-IMPLANTABLE MEDICAL DEVICE). IT WAS NOTED THE EXPLANTED DEVICES WOULD NOT BE RETURNED FOR ANALYSIS.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT NEVER HAD THERAPEUTIC EFFECT. THE TRIAL HELPED WITH THE PAIN A LOT, BUT SINCE HAVING THE IMPLANT IT HAD NOT HELPED WITH HER PAIN AT ALL. IT WAS REPORTED THAT STIMULATION WAS NOT REACHING THE RIGHT AREA, AND THE HCP HAD STATED THAT ¿IT MAY NEVER REACH THERE." THE PATIENT WAS SCHEDULED FOR A THIRD REPROGRAMMING. IT WAS LATER REPORTED THAT THE PATIENT FOUND OUT THE LEAD TO HER NECK AND SHOULDER DIDN¿T WORK. THE PATIENT WAS STILL HAVING CONCERNS, BUT IT WAS UNCLEAR IF THE PATIENT HAD SOUGHT FURTHER HELP.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    273754 PRIMEADVANCED STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF LGW MEDTRONIC MED REL MEDTRONIC PUERTO RICO 37702

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention