BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ACTIVA

    MDR report key: 3864325 · Received June 10, 2014

    Report

    Report Number
    3004209178-2014-11308
    Event Type
    Injury
    Date Received
    June 10, 2014
    Report Date
    May 19, 2014
    Manufacturer
    MEDTRONIC MED REL MEDTRONIC PUERTO RICO
    Product Code
    MHY
    PMA / PMN Number
    P960009
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    CONCOMITANT PRODUCTS: PRODUCT ID 3389S-40, LOT# V944205, IMPLANTED: (B)(6) 2013, PRODUCT TYPE LEAD; PRODUCT ID 3389S-40, LOT# V425792, IMPLANTED: (B)(6) 2010, PRODUCT TYPE LEAD; PRODUCT ID 3389S-40, LOT# V425792, IMPLANTED: (B)(6) 2010, EXPLANTED: (B)(6) 2013, PRODUCT TYPE LEAD; PRODUCT ID 37751, SERIAL# (B)(4), PRODUCT TYPE RECHARGER. (B)(4).

    Additional Manufacturer Narrative · 1

    CONCOMITANT MEDICAL PRODUCTS: PRODUCT ID 3389S-40, LOT# V944205, IMPLANTED: (B)(6) 2013, PRODUCT TYPE: LEAD. PRODUCT ID 3389S-40, LOT# V425792, IMPLANTED: (B)(6) 2010, PRODUCT TYPE: LEAD. PRODUCT ID 3389S-40, LOT# V425792, IMPLANTED: (B)(6) 2010, EXPLANTED: (B)(6) 2013, PRODUCT TYPE: LEAD. PRODUCT ID 37751, SERIAL# (B)(4), PRODUCT TYPE: RECHARGER. (B)(4). ANALYSIS RESULTS WERE NOT AVAILABLE AS OF THE DATE OF THIS REPORT. A FOLLOW-UP REPORT WILL BE SUBMITTED WHEN ANALYSIS IS COMPLETE.

    Additional Manufacturer Narrative · 1

    CONCOMITANT MEDICAL PRODUCTS: PRODUCT ID 3389S-40, LOT# V944205, IMPLANTED: (B)(6) 2013, PRODUCT TYPE: LEAD. PRODUCT ID 3389S-40, LOT# V425792, IMPLANTED: (B)(6) 2010, PRODUCT TYPE: LEAD. PRODUCT ID 3389S-40, LOT# V425792, IMPLANTED: (B)(6) 2010, EXPLANTED: (B)(6) 2013, PRODUCT TYPE: LEAD. PRODUCT ID 37751, SERIAL# (B)(4), PRODUCT TYPE: RECHARGER. ANALYSIS OF THE IMPLANTABLE NEUROSTIMULATOR FOUND THE DEVICE WAS FUNCTIONALLY OK AND ANOMALIES WERE INSIGNIFICANT.

    Additional Manufacturer Narrative · 1

    IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THERE WERE PROBLEMS RECHARGING. IT WAS NOTED THAT THE PATIENT HAD A HARD TIME CHARGING. IT WAS NOTED THAT EVER SINCE IMPLANT THE PATIENT HAD PROBLEMS CHARGING. IT WAS NOTED THAT THE PATIENT USUALLY ONLY GOT 4 BARS AND IT TOOK A LOT OF ADJUSTING OF HER BODY AND SHE HAD TO ¿PROP HER BOOB UP.¿ PATIENT HAD SEEN THE MANUFACTURING REPRESENTATIVE LAST IN (B)(6) 2013. IT WAS NOTED THAT AFTER 1.5 HOURS OF CHARGING THE PATIENT ONLY GOT TO 50% AND THE CHARGE WOULD ONLY LAST ABOUT 6 HOURS. IT WAS NOTED THAT THE FIRST TIME THE IMPLANTABLE NEUROSTIMULATOR (INS) WAS TOO DEEP AND THEY WENT BACK IN AND MOVED THE INS AND HAD TO REDO ONE OF THE LEADS IN (B)(6) 2013. THE RECHARGER WOULD NOT FULLY CHARGE THE IMPLANT. ANOMALY APPEARED TO HAVE OCCURRED THROUGH PRODUCT USE. THERE WAS NO INDICATION OF PATIENT HARM. IT WAS LATER REPORTED COUPLING SEEMED TO BE THE ISSUE WITH THE RECHARGEABLE DEVICE. IT WAS NOTED THAT THE PATIENT WOULD RECHARGE FOR 45 MINUTES TO AN HOUR DAILY AND GET UP TO 50%. IT WAS NOTED THAT THE RECHARGER SEEMED TO DEPLETE MUCH QUICKER. PATIENT HAD A ¿FAULTY¿ ELECTRODE ON THE RIGHT SIDE AND HAD SURGERY TO REPLACE THE LEAD IN (B)(6) 2013. ADDITIONAL INFORMATION RECEIVED REPORTED THE PATIENT WAS STILL HAVING CONCERNS WITH THEIR DEVICE OR THERAPY BUT WAS WORKING WITH THEIR HEALTHCARE PROFESSIONAL OR MANUFACTURING REPRESENTATIVE. IT WAS NOTED THAT THE PATIENT HAD AN APPOINTMENT SCHEDULED FOR (B)(6) 2014.

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION RECEIVED REPORTED THE DEVICE WAS DIFFICULT TO CHARGE SO THE HEALTHCARE PROFESSIONAL HAD WANTED TO REPLACE THE DEVICE. THE DEVICE EXPLANT OCCURRED ON (B)(6) 2014. THERE WAS A PERFORMANCE ISSUE. THE DEVICE WAS DIFFICULT TO CHARGE AND HAD TAKEN A LONG TIME TO CHARGE. THERE WERE NO PATIENT COMPLICATIONS. THERE WAS A POSSIBLE DEFECTIVE DEVICE.

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION RECEIVED REPORTED THE FIRST SURGERY HAD NOT IMPROVED THE RECHARGING SO A SECOND SURGERY WAS DONE. THE PATIENT WAS HAVING A MUCH EASIER TIME RECHARGING.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    340505 ACTIVA STIMULATOR, ELECTRICAL, IMPLANTED, FOR PARKINSONIAN TREMOR MHY MEDTRONIC MED REL MEDTRONIC PUERTO RICO 37612

    Patients

    Seq Age Sex Outcome Treatment
    1 00049 YR Required Intervention