BEUDAMED
    FDA Adverse Event Injury Summary report: N

    KINETRA

    MDR report key: 2855077 · Received December 3, 2012

    Report

    Report Number
    3004209178-2012-11093
    Event Type
    Injury
    Date Received
    December 3, 2012
    Report Date
    November 7, 2012
    Manufacturer
    MEDTRONIC MED REL MEDTRONIC PUERTO RICO
    Product Code
    MHY
    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 ID 7482A51, , SERIAL# (B)(4), IMPLANTED: (B)(6) 2011, PRODUCT TYPE EXTENSION; PRODUCT ID 7482A51, SERIAL# (B)(4), IMPLANTED: (B)(6) 2011, PRODUCT TYPE EXTENSION; PRODUCT ID 7436, SERIAL# (B)(4), PRODUCT TYPE PROGRAMMER, PATIENT; PRODUCT ID 3389S-40, LOT# V589335, IMPLANTED: (B)(6) 2011, PRODUCT TYPE LEAD; PRODUCT ID 3389S-40, LOT# V589335, IMPLANTED: (B)(6) 2011, PRODUCT TYPE LEAD. (B)(4).

    Additional Manufacturer Narrative · 1

    (B)(4).

    Additional Manufacturer Narrative · 1

    ADDITIONAL INFORMATION ON THE INITIAL REPORTER'S ADDRESS ADDED. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT "NEVER HAD GOOD THERAPY" SINCE IMPLANT. AN X-RAY OF THE LEADS WAS TAKEN WHICH SHOWED THAT THE LEAD PLACEMENT WAS "GOOD" AND THERE WERE NO FRACTURES. IT WAS INDICATED THAT TWO ELECTRODE CONTACT PAIRS HAD READINGS OF LESS THAN 50 MICROAMPERES. THE PATIENT REPORTEDLY DID NOT FEEL ANY SHOCKING SENSATION AT THE POCKET OR LEAD/EXTENSION CONNECTION. IT WAS NOTED THAT THE DOCTOR WILL SCHEDULE A REVISION. IF ANY ADDITIONAL INFORMATION IS RECEIVED, A FOLLOW-UP REPORT WILL BE SENT.

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION INDICATED THE CAUSE OF THE EVENT WAS THAT "THE IMPLANTABLE NEUROSTIMULATOR (INS) SHOWED SIMILAR IMPEDANCES ACROSS VARIOUS CONTACTS AND ON BOTH SIDES." RIGHT SIDE SHOWED HIGH IMPEDANCES AND LOW CURRENT. PATIENT WAS REFERRED FOR RE-INTERROGATION OF THE INS AS INTERVENTION. PREVIOUSLY REPORTED X-RAY ASSESSMENT WAS CONDUCTED ON (B)(6) 2012. INSUFFICIENT BENEFIT WAS NOTED AS A SYMPTOM. THERE WERE NO HOSPITALIZATION OR INJURY REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 KINETRA STIMULATOR, ELECTRICAL, IMPLANTED, FOR PARKINSONIAN TREMOR MHY MEDTRONIC MED REL MEDTRONIC PUERTO RICO 7428

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention