BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PRIMEADVANCED

    MDR report key: 3042230 · Received April 9, 2013

    Report

    Report Number
    3004209178-2013-04905
    Event Type
    Injury
    Date Received
    April 9, 2013
    Report Date
    April 4, 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
    NE, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    PRODUCT ID: 37746, SERIAL# (B)(4), PRODUCT TYPE: PROGRAMMER. PATIENT PRODUCT ID: 39286-65, SERIAL# (B)(4), IMPLANTED: (B)(6) 2012, PRODUCT TYPE: LEAD. PRODUCT ID: 39286-65, SERIAL# (B)(4), IMPLANTED: (B)(6) 2012, PRODUCT TYPE: LEAD. (B)(4).

    Description of Event or Problem · 1

    IT WAS ORIGINALLY REPORTED THAT THE STIMULATION WAS NOT GOING TO PATIENT'S BACK. IT WAS STATED SHE HAD THE STIMULATOR INSTALLED FOR BACK AND LEGS AND IT WAS WORKING FOR HER LEGS BUT DID NOT GET ANY STIMULATION IN HER BACK DESPITE REPROGRAMMING ATTEMPTS. IT WAS STATED THAT, "PERHAPS, THE STIMULATOR WAS DEFECTIVE." THE PATIENT DID GO THROUGH A TRIAL PRIOR TO IMPLANT AND IT DID WORK FOR HER BACK. IT WAS STATED SHE HAD ALREADY TRIED ALL OF THE PROGRAMS SHE HAD AVAILABLE AT THE TIME. MORE THAN TWO WEEKS LATER IT WAS REPORTED THAT THE PATIENT WAS STILL HAVING CONCERNS REGARDING HER DEVICE OR THERAPY BUT SHE WAS WORKING WITH THE DOCTOR OR REPRESENTATIVE. IT WAS ALSO NOTED THE PATIENT WAS NOT HAPPY WITH IT BECAUSE IT DIDN'T WORK IN HER BACK, JUST HER LEGS. LESS THAN TWO MONTHS LATER, IT WAS REPORTED THAT THE PATIENT HAD 2X8 SURGICAL LEAD AND A PERCUTANEOUS LEAD ON ONE SIDE MIGHT POTENTIALLY BE ADDED ON THE DAY OF THE REPORT. IT WAS STATED THAT THE PATIENT HAD LOSS OF THERAPY ON ONE SIDE. HEALTHCARE PROFESSIONAL (HCP) WAS GOING TO TRY TO REPOSITION EXISTING 2X8 SURGICAL LEAD AND, IF THAT DIDN'T RE-ESTABLISH COVERAGE, A PERCUTANEOUS LEAD ON THE SIDE WHERE THE STIMULATION HAD BEEN LOST WOULD BE ADDED. ADDITIONAL INFORMATION HAS BEEN REQUESTED BUT WAS NOT AVAILABLE AS OF THE DATE OF THIS REPORT. WHEN RECEIVED, A SUPPLEMENTAL REPORT WILL BE SUBMITTED.

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION RECEIVED REPORTED THAT REPOSITIONING THE LEAD RESOLVED THE ISSUE AND THAT THE LEAD HAD NOT MIGRATED. IT WAS NOTED THAT A NEW LEAD WAS NOT IMPLANTED. IT WAS FURTHER NOTED THAT DIAGNOSTIC TESTING WAS PERFORMED. IT WAS NOTED THAT THE CAUSE OF LOSS OF STIMULATION WAS DUE TO LEAD POSITION. IT WAS FURTHER NOTED THAT THE PATIENT WAS RECEIVING EFFECTIVE THERAPY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    146690 PRIMEADVANCED STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF LGW MEDTRONIC MED REL MEDTRONIC PUERTO RICO 37702

    Patients

    Seq Age Sex Outcome Treatment
    1 00038 YR Required Intervention