BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PRIMEADVANCED

    MDR report key: 3130255 · Received May 24, 2013

    Report

    Report Number
    3004209178-2013-08187
    Event Type
    Injury
    Date Received
    May 24, 2013
    Report Date
    May 7, 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
    NY, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    CONCOMITANT PRODUCTS: PRODUCT ID 3778-45, SERIAL# (B)(4), IMPLANTED: (B)(6) 2012, PRODUCT TYPE LEAD; PRODUCT ID 3778-45, SERIAL# (B)(4), IMPLANTED: (B)(6) 2012, PRODUCT TYPE LEAD. (B)(4).

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THE RIGHT SIDE WAS NOT WORKING; IT WORKED ¿FINE¿ FOR A WEEK TO A WEEK AND A HALF AND THEN THE PATIENT HAD NO SENSATION. A MONTH AFTER SURGERY, THEY DETERMINED THE PATIENT¿S LEAD ¿FLIPPED OR POPPED OUT.¿ IN (B)(6) THE PATIENT HAD ANOTHER SURGERY AND IT ONLY WORKED FOR 4 DAYS. IT WAS NOTED THE RECOVERY WAS DIFFICULT FOR THE PATIENT. THE PATIENT HAD BEEN ABLE TO CONTROL ABOUT 60% OF HER PAIN WITH JUST THE LEFT SIDE; SHE¿S STILL TAKING MEDICATION BUT LESS IBUPROFEN AND MUSCLE RELAXANTS. THE PATIENT WAS STILL SENSITIVE TO LIGHT. IT WAS REPORTED IF BOTH SIDES WORKED THE PATIENT WOULD BE AT 90% RELIEF. THE PATIENT WAS TOLD ¿THERE WAS NO GUARANTEE THAT THE THIRD SURGERY WOULD GIVE BETTER RESULTS GIVEN THE LOCATION OF THE IMPLANT.¿ ADDITIONAL INFORMATION HAS BEEN REQUESTED BUT WAS NOT AVAILABLE AS OF THE DATE OF THIS REPORT; A FOLLOW-UP REPORT WILL BE SENT IF INFORMATION BECOMES AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    232668 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