BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ACTIVA

    MDR report key: 6102630 · Received November 15, 2016

    Report

    Report Number
    3004209178-2016-23996
    Event Type
    Injury
    Date Received
    November 15, 2016
    Date of Event
    March 20, 2015
    Report Date
    February 15, 2017
    Manufacturer
    MEDTRONIC PUERTO RICO OPERATIONS CO.
    Product Code
    MHY
    UDI-DI
    00643169529762
    PMA / PMN Number
    P960009
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    ANALYSIS OF THE INS 37612 ACTIVARC MVD S/N (B)(4) FOUND NO ANOMALIES. ACCORDING TO THE TRACE REPORT OBTAINED FROM THE INS, THE TOTAL RECHARGE COUNT WAS 813. THE LAST RECORDED RECHARGE SESSION PERFORMED WHILE THE DEVICE WAS IMPLANTED WAS ON (B)(6) 2016. THE DEVICE WAS RECHARGED FOR 30 MINUTES AND THE BATTERY CHARGED FROM 3.71V TO 3.75V. A PRIOR CHARGE OCCURRED ON (B)(6) 2016; IT LASTED 44 MINUTES AND THE BATTERY CHARGED FROM 3.76V TO 3.78V. THE PARAMETER TREND DIAGNOSTIC SECTION OF THE TRACE REPORT SHOWS PATIENT USAGE DURING THIS SESSION. OF THE LAST SIX RECHARGE SESSIONS RECORDED, THREE SESSIONS HAD NO BARS (0 COUPLING). ONLY ONE SESSION WAS ABLE TO OBTAIN 8 BARS OF COUPLING. THIS COULD POTENTIALLY BE CAUSED BY THE INS BEING IMPLANTED TOO DEEP AS REPORTED ON THE RETURNED INFORMATION. RECHARGING OF THE INS WAS DONE AT SPACINGS OF 0 CM, 1 CM, 2 CM AND 3 CM TO SEE HOW MANY COUPLING BARS THE INS COULD OBTAIN. AT 0 CM SPACING THERE WERE 8 BARS, AT 1 CM THERE WERE 8 BARS, AT 2 CM THERE WERE 3 BARS, AND AT 3 CM THERE WERE 0 BARS. THE SAME COUPLING WAS OBSERVED ON A KNOWN GOOD ACTIVA RC INS, INDICATING THAT THIS INS IS WORKING CORRECTLY WITH A RECHARGER. A GOOD FAITH EFFORT WILL BE MADE TO OBTAIN THE APPLICABLE INFORMATION RELEVANT TO THE REPORT. IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Additional Manufacturer Narrative · 1

    (B)(4).

    Additional Manufacturer Narrative · 1

    INFORMATION REFERENCES THE MAIN COMPONENT OF THE SYSTEM AND OTHER APPLICABLE COMPONENTS ARE: PRODUCT ID: 3389S-40, LOT# VA0074G, IMPLANTED: (B)(6) 2012, PRODUCT TYPE: LEAD. A GOOD FAITH EFFORT WILL BE MADE TO OBTAIN THE APPLICABLE INFORMATION RELEVANT TO THE REPORT. IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Additional Manufacturer Narrative · 1

    A GOOD FAITH EFFORT WILL BE MADE TO OBTAIN THE APPLICABLE INFORMATION RELEVANT TO THE REPORT. IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Additional Manufacturer Narrative · 1

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

    Additional Manufacturer Narrative · 1

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

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION WAS RECEIVED FROM A PATIENT AND LATER A MANUFACTURER REPRESENTATIVE (REP). IT WAS REPORTED THAT THE PATIENT WAS SCHEDULED FOR A REPLACEMENT SURGERY ON (B)(6) 2016. IT WAS ALSO STATED THAT "THE DEVICE SEEMS LIKE SOMETHING IS WRONG." THE PATIENT ALSO NOTED THAT DURING THE IMPLANT SURGERY IN (B)(6) 2015, THE PATIENT WAS CLOSED UP AND WHEN THEY "CAME TO", THEY WERE TOLD THEY WOULD HAVE TO GO BACK IN. IT WAS THEN STATED THAT THE PATIENT WAS NOT GIVEN A REASON REGARDING THE IMPLANTABLE NEUROSTIMULATOR (INS) NOT WORKING SINCE IMPLANT AND DID NOT KNOW WHAT CAUSED THE ISSUE; THE PATIENT SPECULATED IT WAS A FAULTY PRODUCT. THE MANUFACTURER REPRESENTATIVE (REP) LATER CONFIRMED THAT THE DEVICE WAS REMOVED ON (B)(6) 2016.

    Description of Event or Problem · 1

    FOLLOW-UP WAS RECEIVED FROM THE PATIENT WHO STATED THAT THEY WERE HAVING A LEAD ISSUE. THE PATIENT STATED THAT AT HER LAST IMPLANTABLE NEUROSTIMULATOR (INS) IMPLANT SURGERY, THEY WERE IN RECOVERY WHEN THEY HAD TO GO BACK INTO SURGERY TO FIX A LEAD ISSUE. PATIENT STATED THAT THEY WERE ALSO SCHEDULED FOR ANOTHER SURGERY ON (B)(6) 20166 BECAUSE THEIR INS IS ¿FAULTY¿ AND HAS NOT WORKED SINCE SHE WAS IMPLANTED. THEY ADDED THAT THIS WOULD BE THEIR 4TH SURGERY IN 4 YEARS AND THEY ¿LOSE A LITTLE BRAIN FUNCTION¿ EVERY TIME THEY GO INTO SURGERY.

    Description of Event or Problem · 1

    INFORMATION WAS RECEIVED FROM A PATIENT WHO WAS IMPLANTED WITH A NEUROSTIMULATOR FOR PARKINSON'S DUAL AND MOVEMENT DISORDERS. IT WAS REPORTED THAT THE PATIENT EXPERIENCED A DIFFICULTY CHARGING AS THE DEVICE WAS TAKING TOO LONG TO CHARGE AND THE PATIENT CAN ONLY ACHIEVE 4 COUPLING BARS; POOR COUPLING WAS REPORTED. THE PATIENT ALSO NOTED THAT THE DEVICE WAS IMPLANTED TOO DEEP AND THE POCKET MAY BE TOO BIG SO THERE WAS A REVISION SCHEDULED FOR (B)(6) 2016. IT WAS ALSO STATED THAT THE IMPLANTABLE NEUROSTIMULATOR (INS) HASN'T WORKED SINCE SHE HAD IT IMPLANTED. THERE WAS NO KNOWN IMPACT OR CONSEQUENCE TO THE PATIENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    754388 ACTIVA STIMULATOR, ELECTRICAL, IMPLANTED, FOR PARKINSONIAN TREMOR MHY MEDTRONIC PUERTO RICO OPERATIONS CO. 37612 00643169529762

    Patients

    Seq Age Sex Outcome Treatment
    1 50 YR Required Intervention