BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ACTIVA

    MDR report key: 4054969 · Received September 3, 2014

    Report

    Report Number
    3004209178-2014-16280
    Event Type
    Injury
    Date Received
    September 3, 2014
    Report Date
    August 8, 2014
    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
    NJ, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    CONCOMITANT MEDICAL PRODUCTS: PRODUCT ID 7482A51, SERIAL# (B)(4), IMPLANTED: (B)(6) 2007, PRODUCT TYPE: EXTENSION; PRODUCT ID 3387S-40, LOT# V022287, PRODUCT TYPE: LEAD; PRODUCT ID 37602, SERIAL# (B)(4), IMPLANTED: (B)(6) 2012, PRODUCT TYPE: IMPLANTABLE NEUROSTIMULATOR; PRODUCT ID 7482A51, SERIAL# (B)(4), IMPLANTED: (B)(6) 2007, PRODUCT TYPE: EXTENSION; PRODUCT ID 3387S-40, LOT# V022287, PRODUCT TYPE: LEAD. (B)(4).

    Additional Manufacturer Narrative · 1

    ANALYSIS OF THE IMPLANTABLE NEUROSTIMULATOR (INS) FOUND NO SIGNIFICANT ANOMALY. THE INS BATTERY WAS AT NORMAL END OF LIFE AND T HERE WAS NO TELEMETRY OR OUTPUT. DESTRUCTIVE ANALYSIS OF THE BATTERY CELL SHOWED NORMAL DEPLETION WITH NO INTERNAL SHORTING PATH OR UN-ATTRIBUTABLE DAMAGE TO ANY OF THE CELL COMPONENTS. VISUAL AND DIMENSIONAL INSPECTION FOUND THAT THE BATTERY WAS SWOLLEN. THE SWELLING WAS MOST LIKELY CAUSED BY AN EXTERNAL SHORT OR OTHER MISHANDLING.

    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 COMPLETED.

    Additional Manufacturer Narrative · 1

    IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT WAS SEEN ON (B)(6) 2014 AND THE RIGHT BATTERY WAS AT END OF SERVICE (EOS), 2.15 VOLTS. THE SETTINGS WERE 60US, 130HZ, 2.0V, 3+1- BIPOLAR. THE PATIENT HAD PREVIOUSLY BEEN SEEN ON (B)(6) 2013 AND THERAPY IMPEDANCE HAD BEEN 1123 OHMS, 2.519MA. ON (B)(6) 2014 IMPEDANCES WERE C/0-GREATER THAN 40,000, C/1-485, C/2-2770 ANDC/3-485. BIPOLAR VALUES WERE NOT AVAILABLE. THERAPY IMPEDANCE WAS 1392 OHMS. IT WAS NOTED THAT THIS HAD NO SEEMED RIGHT AS THE PATIENT HAD A SHORT AS INDICATED BY THE CASE VALUES WHICH WAS THE REASON FOR THE DEAD BATTERY. THE PATIENT HAD LOST THERAPY AS A RESULT OF THE PREMATURE BATTERY DEPLETION. THE PATIENT HAD BEEN IMPLANTED WITH TWO DEVICES ON (B)(6) 2012 AND THE DEVICES HAD EVENTUALLY COMPLETELY DEPLETED. ADDITIONAL INFORMATION WAS REQUESTED BUT HAD NOT BEEN RECEIVED AS OF THE DATE OF THIS REPORT.

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION RECEIVED REPORTED THAT THE DEVICE WAS REPLACED. THERE WAS NO PATIENT DEATH OR INJURY.

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION RECEIVED REPORTED THE PATIENT HAD SYMPTOMS OF RIGIDITY. THE IMPLANTABLE NEUROSTIMULATOR (INS) HAD REACHED END OF SERVICE ON (B)(6) 2014 AND WAS REPLACED ON (B)(6) 2014. THE CAUSE OF THE IMPEDANCE ISSUE WAS DETERMINED TO BE DEVICE RELATED. X-RAYS WERE DONE AND THE PATIENT HAD BEEN PROGRAMMED IN CONTINUOUS MODE. FOLLOWING THE REPLACEMENT THE PATIENT HAD RECOVERED WITHOUT PERMANENT IMPAIRMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    539075 ACTIVA STIMULATOR, ELECTRICAL, IMPLANTED, FOR PARKINSONIAN TREMOR MHY MEDTRONIC MED REL MEDTRONIC PUERTO RICO 37602

    Patients

    Seq Age Sex Outcome Treatment
    1 00071 YR Required Intervention