BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ACTIVA

    MDR report key: 6794344 · Received August 15, 2017

    Report

    Report Number
    3004209178-2017-17466
    Event Type
    Injury
    Date Received
    August 15, 2017
    Report Date
    September 22, 2017
    Manufacturer
    MEDTRONIC MED REL MEDTRONIC PUERTO RICO
    Product Code
    MHY
    UDI-DI
    00613994934604
    PMA / PMN Number
    P960009
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    INFORMATION REFERENCES THE MAIN COMPONENT OF THE SYSTEM AND OTHER APPLICABLE COMPONENTS ARE: PRODUCT ID: 37085-40, SERIAL# (B)(4), IMPLANTED: (B)(6) 2012, PRODUCT TYPE: EXTENSION. ANALYSIS RESULTS WERE NOT AVAILABLE AT THE TIME OF THIS REPORT. A FOLLOW-UP REPORT WILL BE SENT WHEN ANALYSIS IS COMPLETED. 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

    ANALYSIS OF THE IMPLANTABLE NEUROSTIMULATOR (INS) (SERIAL # (B)(4)) REVEALED THAT THE INS WAS FUNCTIONALLY OKAY WITH INSIGNIFICANT ANOMALIES. ANALYSIS OF THE EXTENSION (SERIAL # (B)(4)) REVEALED THAT ALL CONDUCTOR WIRES IN THE BODY OF THE EXTENSION WERE BROKEN 29CM FROM THE DISTAL END. (B)(4) WAS REPLACED WITH (B)(4) REGARDING THE INS (SERIAL #(B)(4)). (B)(4) WAS REPLACED WITH (B)(4) REGARDING THE EXTENSION (SERIAL #(B)(4)). (B)(4) WAS REPLACED WITH BOTH (B)(4). REGARDING THE INS (B)(4) WAS REPLACED WITH BOTH (B)(4) REGARDING THE EXTENSION. (B)(4) APPLY TO BOTH INS AND EXTENSION. IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Description of Event or Problem · 1

    INFORMATION WAS RECEIVED FROM A HEALTHCARE PROVIDER (HCP) VIA A MANUFACTURER REPRESENTATIVE (REP) REGARDING A PATIENT WITH AN IMPLANTED NEUROSTIMULATOR (INS) FOR ESSENTIAL TREMOR AND MOVEMENT DISORDERS. THE REP REPORTED THAT THE PATIENT HAD A STROKE SOMETIME IN THE LAST FEW YEARS, AND THEIR FAMILY REPORTED THAT THEY HAVE HAD SEVERAL FALLS SINCE THEN. THE EXACT DATES OF THE STROKE AND THE FALLS WERE UNKNOWN. THE REP REPORTED THAT THE PATIENT HAD "SIGNIFICANTLY" HIGH IMPEDANCES ACROSS ALL CONTACT CONFIGURATIONS, WHICH CAUSED A DISRUPTION TO THERAPY. THE REP REPORTED THAT SEVERAL IMPEDANCE CHECKS WERE MADE BY THE HCP, AS WELL AS A CT SCAN TO DIAGNOSE THE ISSUE, ULTIMATELY LEADING TO AN INTRA-OPERATIVE LEAD AND SYSTEM VISUAL INSPECTION AND IMPEDANCE CHECK. THE REP REPORTED THAT THE MANAGING HCP TURNED THE PATIENT'S VOLTAGE TO 0.0V AND SCHEDULED A SURGICAL INTERVENTION. THE HCP TESTED THE LEAD IMPEDANCES AND ONLY CONTACT 0, WHICH WAS UNUSED, HAD ISSUES. THE HCP THEN REPLACED THE PATIENT'S EXTENSION AND INS. THE REP REPORTED THAT INTRA-OP TESTING SHOWED THE IMPEDANCES OUTSIDE OF CONTACT 0 WERE RETURNED TO NORMAL RANGE. PRE-OP IMPEDANCE VALUES WERE GIVEN AS: C & 0 16562 OHMS; 0 & 2 26601 OHMS; C & 1 16927 OHMS; 0 & 3 17976 OHMS; C & 2 12958 OHMS; 1 & 2 29867 OHMS; C & 3 17383 OHMS; 1 & 3 29044 OHMS; 0 & 1 23798 OHMS; 2 & 3 27056 OHMS. INTRA-OP IMPEDANCE VALUES WERE GIVEN AS: C & 0 13280 OHMS; 0 & 2 15718 OHMS; C & 1 873 OHMS; 0 & 3 15876 OHMS; C & 2 803 OHMS; 1 & 2 1111 OHMS; C & 3 808 OHMS; 1 & 3 1235 OHMS; 0 & 1 14697 OHMS; 2 & 3 1089 OHMS. NO FURTHER PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    575902 ACTIVA STIMULATOR, ELECTRICAL, IMPLANTED, FOR PARKINSONIAN TREMOR MHY MEDTRONIC MED REL MEDTRONIC PUERTO RICO 37601 00613994934604

    Patients

    Seq Age Sex Outcome Treatment
    1 Other| R