BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ACTIVA

    MDR report key: 3111378 · Received May 14, 2013

    Report

    Report Number
    3007566237-2013-01609
    Event Type
    Injury
    Date Received
    May 14, 2013
    Report Date
    May 2, 2013
    Manufacturer
    MEDTRONIC NEUROMODULATION
    Product Code
    MHY
    PMA / PMN Number
    P960009
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MN, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    CONCOMITANT MEDICAL PRODUCTS: PRODUCT ID 37085-40, SERIAL# (B)(4), IMPLANTED: (B)(6) 2009, EXPLANTED: (B)(6) 2013. PRODUCT TYPE: EXTENSION: PRODUCT ID 37085-40, SERIAL# (B)(4), IMPLANTED: (B)(6) 2009, EXPLANTED: (B)(6) 2013. PRODUCT TYPE: EXTENSION. (B)(4). (B)(6).

    Additional Manufacturer Narrative · 1

    (B)(4).

    Additional Manufacturer Narrative · 1

    FINAL DEVICE ANALYSIS REVEALED THAT THE DISTAL END CONDUCTORS WERE BROKEN DUE TO OVERSTRESS/DAMAGE. THE #0 CONDUCTOR WAS BROKEN AT THE #0 DISTAL CONNECTOR CRIMP SLEEVE 0.8 CM FROM THE DISTAL END. ALSO, THE #0 CONDUCTOR WAS SHORTED TO THE #2 DISTAL CONNECTOR BLOCK 1.5 CM FROM THE DISTAL END DUE TO OVERSTRESS. THE #1 CONDUCTOR WAS BROKEN AT THE #1 DISTAL CONNECTOR CRIMP SLEEVE 1.3 CM FROM THE DISTAL END DUE TO OVERSTRESS. THE #1 COILED CONDUCTOR WAS STRETCHED AT THE COIL-STRAIGHT WIRE CRIMP SLEEVE AND BOTH THE #0 AND #1 CONDUCTORS WERE KINKED AT THE #2 DISTAL CONNECTOR BLOCK. IT WAS SUSPECTED THAT THE OVERSTRESS OBSERVED AT THE DISTAL END OCCURRED WHILE THE INS WAS IMPLANTED AND WAS NOT THE RESULT OF EXPLANT DAMAGE.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE EXTENSION WAS EXPLANTED. IT WAS STATED THAT THERE WERE IMPEDANCE "ISSUES," INCLUDING BOTH HIGH AND LOW IMPEDANCE MEASUREMENTS. INTRA-OPERATIVE IMPEDANCE MEASUREMENTS ON THE EXTENSION AND THE LEAD WERE PERFORMED, BUT IT WAS FOUND THAT THE EXTENSION "WAS THE PROBLEM." THE EXTENSION WAS REPLACED AND IMPEDANCES WERE BACK TO NORMAL. IT WAS STATED THAT THE SYMPTOMS WERE "SUBOPTIMAL" THERAPEUTIC RESULTS BECAUSE "SEVERAL" CONTACTS ON THE LEAD COULD NOT BE USED. HOSPITALIZATION WAS REQUIRED. A SUPPLEMENTAL REPORT WILL BE SENT IF ANY ADDITIONAL INFORMATION IS RECEIVED.

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION SHOWED THE HIGH IMPEDANCES WERE BETWEEN CONTACTS C-9 (10687 OHMS) AND LOW IMPEDANCES WERE BETWEEN CONTACTS 8-10 (38 OHMS). IT WAS STATED THE EXTENSION WAS DAMAGED OR BROKEN AT THE DISTAL CONNECTOR SITE.

    Description of Event or Problem · 1

    IT WAS FURTHER REPORTED THAT THE PATIENT WAS DOING FINE. OF NOTE, THE STIMULATOR HAD THE ELECTIVE REPLACEMENT INDICATOR PRESENT AND WAS ALSO REPLACED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    212536 ACTIVA STIMULATOR, ELECTRICAL, IMPLANTED, FOR PARKINSONIAN TREMOR MHY MEDTRONIC NEUROMODULATION 37601

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization| R