BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PRIMEADVANCED

    MDR report key: 3881333 · Received June 18, 2014

    Report

    Report Number
    3004209178-2014-11760
    Event Type
    Malfunction
    Date Received
    June 18, 2014
    Date of Event
    May 17, 2014
    Report Date
    May 27, 2014
    Manufacturer
    MEDTRONIC MED REL MEDTRONIC PUERTO RICO
    Product Code
    LGW
    PMA / PMN Number
    P840001
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    CONCOMITANT MEDICAL PRODUCTS: PRODUCT ID: 3777-75, SERIAL# (B)(4), IMPLANTED: (B)(6) 2011, PRODUCT TYPE: LEAD. PRODUCT ID: 3587A, LOT# L35994, IMPLANTED: (B)(6) 1995, PRODUCT TYPE: LEAD. PRODUCT ID: 37743, SERIAL# (B)(4), PRODUCT TYPE: PROGRAMMER, PATIENT. PRODUCT ID: 7495-66, SERIAL# (B)(4), IMPLANTED: (B)(6), 1995, PRODUCT TYPE: EXTENSION. (B)(4).

    Additional Manufacturer Narrative · 1

    ANALYSIS OF THE IMPLANTABLE NEUROSTIMULATOR (INS) FOUND THAT THERE WAS NO SIGNIFICANT ANOMALY. THE STIMULATION INS BATTERY WAS CONSIDERED NORMAL END OF LIFE AND TELEMETRY AND OUTPUT WAS OKAY.

    Additional Manufacturer Narrative · 1

    ANALYSIS RESULTS WERE NOT AVAILABLE AS OF THE DATE OF THIS REPORT. A FOLLOW-UP REPORT WILL BE SUBMITTED WHEN ANALYSIS IS COMPLETE. (B)(4).

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION RECEIVED REPORTED THAT THERE WAS AN ELECTIVE PROPHYLACTIC REPLACEMENT OF THE IMPLANTABLE NEUROSTIMULATOR (INS) ON (B)(6) 2014. IT WAS CONSIDERED NORMAL BATTERY DEPLETION. THERE WAS AN ELECTIVE REPLACEMENT INDICATOR (ERI) SHOWING. THERE WAS NO PATIENT DEATH. THE PATIENT STATUS AFTER THE DEVICE WAS REMOVED WAS RECOVERED WITHOUT SEQUELA. ALL IMPEDANCES NORMALIZED AND THE PATIENT WAS RECEIVING EFFECTIVE THERAPY WITH THE NEW INS.

    Description of Event or Problem · 1

    IT WAS REPORTED THE PATIENT SAW A NORMAL ERI ON THEIR PROGRAMMER SCREEN. THE PATIENT HAD SCHEDULED A PRE-OP APPOINTMENT FOR REPLACEMENT ON 2014-(B)(6).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT CALLED THE MANUFACTURER REPRESENTATIVE TO CHECK THE IMPLANTABLE NEUROSTIMULATOR (INS). IT WAS NOTED THAT THERE WAS BATTERY DEPLETION. THE BATTERY DEPLETION WAS DESCRIBED AS THE PATIENT FELT IT WAS NOT DOING AS GOOD OF JOB IN THE LAST 10 DAYS PRIOR TO REPORT AS IN THE PREVIOUS 2.5 YEARS. IT WAS NOTED THAT SYMPTOM ASSOCIATED WITH THE EVENT WAS THAT THE PATIENT NEEDED MORE POWER FOR THE SAME PAIN RELIEF IN THE RIGHT ARM. IT WAS NOTED THAT THE PATIENT WANTED TO DECIDE ABOUT A REPLACEMENT AFTER VACATION IN JULY. IT WAS NOTED THAT THE INS VOLTAGE MEASUREMENT WAS 2.69V. IT WAS NOTED THAT NO ACTIONS WERE REQUIRED AS A RESULT. DIAGNOSTIC TESTING OR TROUBLESHOOTING REGARDING THIS INCLUDED IMPEDANCE TESTING AND REPROGRAMMING. IT WAS NOTED THAT THIS ISSUE WAS RESOLVED AND THE CAUSE OF ISSUE WAS DETERMINED. THE ISSUE WAS SPECIFIED AS BEING LOW VOLTAGE ON IMPEDANCE CHECK. IT WAS ALSO NOTED THAT HIGH IMPEDANCE OF OVER 10,000 OHMS WAS OBSERVED ON CONTACT THREE. HOWEVER, IT WAS NOTED THAT THEY WERE NOT USING CONTACT THREE AS OF THE DATE OF REPORT OR IN THE PAST. ACTIONS REQUIRED AS A RESULT OF THIS INCLUDED REPROGRAMMING. DIAGNOSTIC TESTING OR TROUBLESHOOTING INCLUDED IMPEDANCE TESTING AND REPROGRAMMING. THE HIGH IMPEDANCE ISSUE WAS NOT RESOLVED AND THE CAUSE OF WAS NOT DETERMINED. THE EVENT OCCURRED DURING NORMAL USE. THE PRODUCT STATUS OF THE INS WAS IMPLANTED AND REMAINS IN SERVICE. THE PATIENT¿S STATUS WAS ALIVE WITH NO INJURY. LATER IN THE SAME DAY IT WAS REPORTED BY THE MANUFACTURER REPRESENTATIVE THAT THE PATIENT STATED THE DEVICE WAS NOT GIVING THE PATIENT ¿ENOUGH PUNCH¿ FOR THE LAST TEN DAYS PRIOR TO REPORT. THE CALLER STATED THAT THE BATTERY AS AT 2.69V AND ¿WANTED TO KNOW WHERE THE BATTERY WAS AT.¿ IT WAS REVIEWED WITH THE CALLER THAT THE ELECTIVE REPLACEMENT INDICATOR (ERI) WOULD APPEAR AT 2.6V AND END OF SERVICE (EOS) WAS AT 2.2V. IT WAS NOTED THAT THE MANUFACTURER REPRESENTATIVE WAS NOTIFIED OF THE ISSUE ON THE DATE OF REPORT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    357308 PRIMEADVANCED STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF LGW MEDTRONIC MED REL MEDTRONIC PUERTO RICO 37702

    Patients

    Seq Age Sex Outcome Treatment
    1 00056 YR