BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ACTIVA

    MDR report key: 7224772 · Received January 29, 2018

    Report

    Report Number
    3004209178-2018-01534
    Event Type
    Injury
    Date Received
    January 29, 2018
    Report Date
    June 25, 2018
    Manufacturer
    MEDTRONIC PUERTO RICO OPERATIONS CO.
    Product Code
    MHY
    UDI-DI
    00613994761057
    PMA / PMN Number
    P960009
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    PRODUCT ANALYSIS OF THE IMPLANTABLE NEUROSTIMULATOR SERIAL (B)(4) FOUND NO SIGNIFICANT ANOMALIES/BATTERY NOT IN NEW CONDITION. ANALYSIS OF THE EXTENSIONS SERIAL (B)(4) AND (B)(4) FOUND NO SIGNIFICANT ANOMALIES/EXTENSION BODY CUT THROUGH/PRODUCT SEGMENTED FDC NO LONGER APPLIES. IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Additional Manufacturer Narrative · 1

    CONCOMITANT PRODUCT(S): PRODUCT ID: 37602, SERIAL# (B)(4), IMPLANTED: (B)(6) 2015, PRODUCT TYPE: IMPLANTABLE NEUROSTIMULATOR. IT WAS NOTED THAT THE PATIENT HAD 2 IMPLANTABLE NEUROSTIMULATORS (INS) PRESENT DURING THE EVENT. SEE MANUFACTURER¿S REPORT #30042091 78-2018-01533 FOR THE CONCOMITANT INS INFORMATION. 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

    CONCOMITANT MEDICAL PRODUCTS: THE MAIN COMPONENT OF THE SYSTEM AND OTHER APPLICABLE COMPONENTS ARE: PRODUCT ID: 748251, SERIAL#: (B)(4), IMPLANTED: 2004 (B)(6), EXPLANTED: 2018 (B)(6), PRODUCT TYPE: EXTENSION. PRODUCT ID: 748251, SERIAL#: (B)(6), IMPLANTED: 2004-(B)(6), EXPLANTED: 2018 (B)(6), PRODUCT TYPE: EXTENSION. IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Additional Manufacturer Narrative · 1

    ANALYSIS RESULTS WERE NOT AVAILABLE AT THE TIME OF THIS REPORT. A FOLLOW-UP REPORT WILL BE SENT WHEN ANALYSIS IS COMPLETE IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Description of Event or Problem · 1

    INFORMATION WAS RECEIVED FROM THE HEALTHCARE PROFESSIONAL (HCP) VIA THE MANUFACTURER¿S REPRESENTATIVE REGARDING A PATIENT WITH AN IMPLANTABLE NEUROSTIMULATOR (INS) FOR MOVEMENT DISORDERS. IT WAS REPORTED THAT THERE WAS AN OPEN CIRCUIT SEEN ON CONTACT 2 AND ALL BIPOLAR COMBINATIONS WITH CONTACT 2 DURING AN IMPEDANCE CHECK OF THE INS ON THE LEFT SIDE. THE DEVICE WAS ALSO INTERROGATED WITH THE CLINICIAN PROGRAMMER. AS A PATIENT FACTOR FOR THE ISSUE, THE PATIENT, PER THE PHYSICIAN, HAS HAD SEVERAL FALLS WHICH WERE UNRELATED TO THE INS THERAPY. NO FURTHER ACTIONS/INTERVENTIONS FOR THIS ISSUE HAD OCCURRED AS CONTACT 3 WAS THE THERAPEUTIC CONTACT FOR THE PATIENT BUT A SURGICAL INTERVENTION WAS PLANNED FOR (B)(6) 2018 (INS REPLACEMENT) WHERE THE SURGEON MAY OR MAY NOT REPLACE THE EXTENSION DEPENDING ON THE SOURCE OF THE OPEN CIRCUITS. IN ADDITION, IT WAS REPORTED THAT THE PATIENT REPORTED A SHOCKING SENSATION AT THE RIGHT INS POCKET. THERE WAS ALSO AN OPEN CIRCUIT SEEN INVOLVING CONTACT 1 (ON MONOPOLAR AND BIPOLAR COMBINATIONS). IT WAS NOTED WHEN THE PATIENT OR PHYSICIAN PLACED THEIR HAND OVER THE INS POCKET DURING THE IMPEDANCE CHECK, THE IMPEDANCES READ WITHIN NORMAL RANGE. AS A PATIENT FACTOR FOR THE ISSUE, IT WAS AGAIN REPORTED THE PATIENT HAD SEVERAL FALLS UNRELATED TO THE THERAPY. A SURGICAL INTERVENTION WAS PLANNED FOR (B)(6) 2018 WHERE THE INS WAS TO BE REPLACED FOR BATTERY DEPLETION. DURING THE REPLACEMENT PROCEDURE, THE SURGEON WILL EXPLORE THE OPEN CIRCUIT ISSUE WITH A POSSIBLE REPLACEMENT OF THE EXTENSION. ALSO THE INS-EXTENSION CONNECTION COULD BE LOOSE WHICH MAY BE THE SOURCE OF THE OPEN CIRCUIT. THE ISSUE WAS REPORTED AS NOT RESOLVED AT THE TIME OF REPORT.

    Description of Event or Problem · 1

    FOLLOW UP INFORMATION RECEIVED FROM THE MANUFACTURER¿S REPRESENTATIVE REPORTED THAT THE CAUSE OF THE OPEN CIRCUITS AND THE SHOCKING AT THE POCKET SITE WAS NOT DETERMINED. IT WAS REITERATED THAT THE PHYSICIAN SUSPECTED THE FALLS THE PATENT HAD (WHICH WERE UNRELATED TO THE INS/THERAPY) MAY BE THE CAUSE BUT THE PHYSICIAN HAD NO WAY ON KNOWING. IT WAS REPORTED THE BOTH INSS WERE REPLACED DUE TO NORMAL BATTERY DEPLETION. ACTIONS TO RESOLVE THE ISSUE WAS THAT THE PHYSICIAN REPLACED BOTH EXTENSIONS WHICH WERE THEN CONNECTED TO THE NEW BILATERAL INSS. THE IMPEDANCES WERE NOW IN NORMAL RANGE AND THE ISSUES WERE RESOLVED. THERE WERE NO FURTHER COMPLICATIONS REPORTED OR ANTICIPATED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    68485 ACTIVA STIMULATOR, ELECTRICAL, IMPLANTED, FOR PARKINSONIAN TREMOR MHY MEDTRONIC PUERTO RICO OPERATIONS CO. 37602 00613994761057

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention