BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ACTIVA

    MDR report key: 6187897 · Received December 19, 2016

    Report

    Report Number
    3004209178-2016-26805
    Event Type
    Injury
    Date Received
    December 19, 2016
    Date of Event
    November 28, 2016
    Report Date
    February 15, 2017
    Manufacturer
    MEDTRONIC PUERTO RICO OPERATIONS CO.
    Product Code
    MHY
    PMA / PMN Number
    P960009
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    CONCOMITANT MEDICAL PRODUCTS: PRODUCT ID 3708660, LOT# NKN092217V, IMPLANTED: (B)(6) 2015, PRODUCT TYPE: EXTENSION. PRODUCT ID 3708660, LOT# NKN095347V, IMPLANTED: (B)(6) 2016, PRODUCT TYPE: EXTENSION. PRODUCT ID 3389S-40, LOT# VA0PET0, IMPLANTED: (B)(6) 2015, PRODUCT TYPE: LEAD. PRODUCT ID 3389S-40, LOT# VA0UMDX, IMPLANTED: (B)(6) 2015, PRODUCT TYPE: LEAD. PRODUCT ID 3708660, LOT# NKN092217V, IMPLANTED: (B)(6) 2015, PRODUCT TYPE: EXTENSION. PRODUCT ID 3708660, LOT# NKN095347V, IMPLANTED: (B)(6) 2016, PRODUCT TYPE: EXTENSION. 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

    THE STIMULATION LEAD BODY CONDUCTOR WAS BROKEN (OVERSTRESS / DAMAGE) AS THE PROXIMAL END OF THE LEAD WAS SEVERELY STRETCHED AND THE #0 CONDUCTOR BROKE AT THE #0 CONNECTOR WELD SITE. ALL FOUR CONDUCTORS WERE BROKEN 10.7 CM FROM THE DISTAL END. THERE WAS AN IMPRESSION IN THE OUTER INSULATION INDICATING THE LEAD WAS PINCHED AT THIS LOCATION. THE BOOT WAS OK. UPON REVIEW OF THE ANALYSIS RESULTS, IT WAS DETERMINED THAT EVAL CODE CONCLUSION (B)(4) AND EVAL CODE RESULT (B)(4) NO LONGER APPLY. 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 PRODUCTS: PRODUCT ID: 3708660, LOT# NKN092217V, IMPLANTED: (B)(6) 2015, PRODUCT TYPE: EXTENSION. PRODUCT ID: 3708660, LOT# NKN095347V, IMPLANTED: (B)(6) 2016, PRODUCT TYPE: EXTENSION. PRODUCT ID: 3389S-40, LOT# VA0PET0, IMPLANTED: (B)(6) 2015, EXPLANTED: (B)(6) 2016, PRODUCT TYPE: LEAD. PRODUCT ID: 3389S-40, LOT# VA0UMDX, IMPLANTED: (B)(6) 2015, EXPLANTED: (B)(6) 2016, PRODUCT TYPE: LEAD.

    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

    NO NEW INFORMATION WAS RECEIVED.

    Description of Event or Problem · 1

    A HEALTH CARE PROVIDER (HCP) REPORTED VIA A MANUFACTURER REPRESENTATIVE THAT HIGH IMPEDANCES WERE MEASURED ON ALL COMBINATIONS. THE FOLLOWING HIGH IMPEDANCES WERE MEASURED ON THE RIGHT SIDE: C <(>&<)> 8 23590, C <(>&<)> 9 19501, C <(>&<)> 10 13492, C <(>&<)> 11 2540, 8 <(>&<)> 9 19269, 8 <(>&<)> 10 23948, 8 <(>&<)> 11 23767, 9 <(>&<)> 10 15950, 9 <(>&<)> 11 19388, AND 10 <(>&<)> 11 13848. IMPEDANCES WERE MEASURED TO BE WITHIN NORMAL RANGE ON THE LEFT SIDE. IT WAS UNKNOWN WHAT THE IMPLANTABLE NEUROSTIMULATOR (INS) WAS PROGRAMMED TO. THE CAUSE OF THE EVENT WAS UNKNOWN. NO DIAGNOSTICS OR TROUBLESHOOTING WAS DONE AND NO ACTIONS OR INTERVENTION WAS TAKEN. RECONNECTION OR IMPEDANCE MEASUREMENTS FOR BOTH THE LEAD AND THE ADAPTOR MAY BE DONE TO CLARIFY THE DEFECTIVE PART. NO SURGICAL INTERVENTION WAS TAKEN AND IT WAS UNKNOWN IF ANY INTERVENTION WAS PLANNED. THE PATIENT¿S INDICATION FOR USE IS PARKINSON¿S DISEASE.

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION RECEIVED FROM A MANUFACTURER REPRESENTATIVE REPORTED THE PATIENT EXPERIENCED A LOSS OF STIMULATION. TROUBLESHOOTING INCLUDED MEASURING IMPEDANCES. THE HEALTH CARE PROVIDER (HCP) WAS CONSIDERING TO PERFORM AN OPERATION AND CONFIRM THE CONNECTION REGION, BUT THE DATE WAS NOT DETERMINED. THE CAUSE OF THE HIGH IMPEDANCES WAS LOOSENESS AT THE CONNECTION REGION. THE ISSUE WAS NOT RESOLVED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE LEAD WAS REPLACED ON (B)(6) 2016 AND FOLLOWING THE REPLACEMENT, IMPEDANCE VALUES NORMALIZED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    837553 ACTIVA STIMULATOR, ELECTRICAL, IMPLANTED, FOR PARKINSONIAN TREMOR MHY MEDTRONIC PUERTO RICO OPERATIONS CO. 37612

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention