BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ACTIVA

    MDR report key: 3903094 · Received June 30, 2014

    Report

    Report Number
    3004209178-2014-12297
    Event Type
    Injury
    Date Received
    June 30, 2014
    Report Date
    June 17, 2014
    Manufacturer
    MEDTRONIC MED REL MEDTRONIC PUERTO RICO
    Product Code
    MHY
    PMA / PMN Number
    H020007
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WV, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    CONCOMITANT MEDICAL PRODUCTS: PRODUCT ID 37612, SERIAL# (B)(4), IMPLANTED: (B)(6) 2010, PRODUCT TYPE: IMPLANTABLE NEUROSTIMULATOR; PRODUCT ID 64001, LOT# N247539, IMPLANTED: (B)(6) 2010, PRODUCT TYPE: ADAPTER; PRODUCT ID 3387S-40, LOT# V010026, IMPLANTED: (B)(6) 2006, PRODUCT TYPE: LEAD; PRODUCT ID 748251, SERIAL# (B)(4), IMPLANTED: (B)(6) 2006, PRODUCT TYPE: EXTENSION; PRODUCT ID 7438, SERIAL# (B)(4), PRODUCT TYPE: PROGRAMMER, PATIENT; PRODUCT ID 37642, SERIAL# (B)(4), PRODUCT TYPE: PROGRAMMER, PATIENT; PRODUCT ID 37651, SERIAL# (B)(4), PRODUCT TYPE: RECHARGER; PRODUCT ID 64001, LOT# N247537, IMPLANTED: (B)(6) 2010, PRODUCT TYPE: ADAPTER; PRODUCT ID 7482A51, SERIAL# (B)(4), IMPLANTED: (B)(6) 2007, PRODUCT TYPE: EXTENSION; PRODUCT ID 3387S-40, LOT# V055601, IMPLANTED: (B)(6) 2007, PRODUCT TYPE: LEAD. (B)(4).

    Additional Manufacturer Narrative · 1

    CONCOMITANT MEDICAL PRODUCTS: PRODUCT ID 37612, SERIAL# (B)(4), IMPLANTED: (B)(6) 2010, PRODUCT TYPE: IMPLANTABLE NEUROSTIMULATOR. PRODUCT ID 64001, LOT# N247539, IMPLANTED: (B)(6) 2010, PRODUCT TYPE: ADAPTER. PRODUCT ID 3387S-40, LOT# V010026, IMPLANTED: (B)(6) 2006, PRODUCT TYPE: LEAD. PRODUCT ID 748251, SERIAL# (B)(4), IMPLANTED: (B)(6) 2006, PRODUCT TYPE: EXTENSION. PRODUCT ID 7438, SERIAL# (B)(4), IMPLANTED: (B)(6) 2006, PRODUCT TYPE: PROGRAMMER, PATIENT. PRODUCT ID 37642, SERIAL# (B)(4), PRODUCT TYPE: PROGRAMMER, PATIENT. PRODUCT ID 37651, SERIAL# (B)(4), PRODUCT TYPE: RECHARGER. PRODUCT ID 64001, LOT# N247537, IMPLANTED: (B)(6) 2010, PRODUCT TYPE: ADAPTER. PRODUCT ID 7482A51, SERIAL# (B)(4), IMPLANTED: (B)(6) 2007, PRODUCT TYPE: EXTENSION. PRODUCT ID 3387S-40, LOT# V055601, IMPLANTED: (B)(6) 2007, PRODUCT TYPE: LEAD. (B)(4).

    Description of Event or Problem · 1

    IT WAS ORIGINALLY REPORTED ON (B)(6) 2014 THE IMPLANTABLE NEUROSTIMULATOR (INS) ON THE RIGHT SIDE HAD MOVED AND SLID DOWN INTO THE BREAST WHICH CAUSED DIFFICULTY RECHARGING. IT WAS STATED THEY HAD DIFFICULTY RECHARGING THE RIGHT INS. IT WAS NOTED IT TOOK LONGER TO CHARGE BECAUSE IT WAS DIFFICULT TO MAINTAIN THE ANTENNA POSITION. IT WAS NOTED THEY WERE ABLE TO GET 8 COUPLING BARS BUT THE INS WOULD MOVE DURING RECHARGING. IT WAS STATED THEY USED TO BE ABLE TO CHARGE FROM HALFWAY TO FULL IN 30-40 MINUTES BUT AT THE TIME OF REPORT IT COULD TAKE 3 HOURS. IT WAS STATED THE INS BEGAN TO MOVE 3 MONTHS PRIOR TO REPORT. FOUR DAYS LATER IT WAS REPORTED IMPEDANCE TESTING WAS PERFORMED. IT WAS NOTED THE CAUSE OF THE ISSUE WAS NOT DETERMINED. IT WAS STATED THE PATIENT RECEIVED EFFECTIVE THERAPY AT THE TIME OF REPORT. ABOUT TWO MONTHS LATER IT WAS REPORTED THAT THERE WAS A REVISION TO SUTURE THE IMPLANTABLE NEUROSTIMULATOR (INS) TO THE CLAVICULAR FASCIA. IT WAS NOTED THAT IT WAS NOT SUTURED ORIGINALLY AT IMPLANT AND THE PATIENT HAD NOTICED IT MOVING WHEN LYING DOWN. IT WAS FURTHER NOTED THAT THE PATIENT HAD TWO RECHARGEABLE DEVICES AND ONLY ONE NEEDED SUTURING. THERE WERE NO ISSUES WITH RECHARGING AND THE REVISION WAS SCHEDULED FOR (B)(6) 2014. FIVE DAYS LATER IT WAS REPORTED THAT THE IMPLANTABLE NEUROSTIMULATOR (INS) WAS MOVED SUPERIOR AND SUTURED SO IT WOULD NOT MOVE. THE REPORTER CONFIRMED THAT THE PATIENT STATED THAT IT TOOK A LONG TIME TO RECHARGE. THE SURGEON MADE THE IMPLANT DEPTH OF THE INS 1 CM. IT APPEARED TO BE DEEPER PRIOR TO ALTERING THE POCKET. NO PROBLEMS WERE FOUND WHEN AN ELECTRODE IMPEDANCE CHECK WAS PERFORMED. REFER TO MANUFACTURING REPORT #3004209178-2014-08649 AS THE INFORMATION WAS ORIGINALLY ONLY REPORTED ON ONE INS, BUT FOLLOW-UP REVEALED THAT IT WAS UNKNOWN WHICH INS WAS AFFECTED.

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION RECEIVED FROM CONSUMER REPORTED THAT THE PATIENT HAD THEIR BATTERIES REPLACED IN 2014. THE BATTERIES WERE REPLACED BECAUSE ONE OF THE BATTERIES HAD "SLIPPED AND DROPPED DOWN".

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION RECEIVED REPORTED THAT THE LAST TIME THE PATIENT WAS SEEN THE BATTERY WAS CHARGED AT 75% AND ON THE DATE OF THIS REPORT THEY WERE ONLY ABLE TO CHARGE TO 25% AND IT WAS NOT HOLDING A CHARGE. THE PATIENT HAD AN APPOINTMENT SCHEDULED FOR (B)(6) 2014.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    381217 ACTIVA STIMULATOR, ELECTRICAL, IMPLANTED, FOR PARKINSONIAN TREMOR MHY MEDTRONIC MED REL MEDTRONIC PUERTO RICO 37612

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention