BEUDAMED
    FDA Adverse Event Injury Summary report: N

    RESTORE ADVANCED

    MDR report key: 2831850 · Received November 14, 2012

    Report

    Report Number
    3004209178-2012-10250
    Event Type
    Injury
    Date Received
    November 14, 2012
    Report Date
    October 15, 2012
    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
    CA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    PRODUCT ID 39565-30, SERIAL# (B)(4), IMPLANTED: (B)(6) 2007, PRODUCT TYPE LEAD; PRODUCT ID 37752, SERIAL# (B)(4), IMPLANTED: (B)(6) 2007, PRODUCT TYPE RECHARGER; PRODUCT ID 37742, SERIAL# (B)(4), IMPLANTED: (B)(6) 2007, PRODUCT TYPE PROGRAMMER, PATIENT; PRODUCT ID 3708140, SERIAL# (B)(4), IMPLANTED: (B)(6) 2007, PRODUCT TYPE EXTENSION; PRODUCT ID 3708140, SERIAL# (B)(4), IMPLANTED: (B)(6) 2007, PRODUCT TYPE EXTENSION. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THERE WAS A DECREASE IN THERAPEUTIC RESPONSE. THE PATIENT REPORTEDLY LAST REPROGRAMMED DEVICE "ABOUT 3 YEARS AGO," STATING HE FELT THE STIMULATION BUT IT WAS "NOT AS EFFECTIVE AS BEFORE." IT WAS NOTED THAT THE PAIN PATTERN DID NOT CHANGE AND THE PATIENT TURNED THE DEVICE OFF MORE THAN ON. IT WAS STATED THAT "IN THE PAST YEAR," THE PATIENT "NEEDED" TO INCREASE HIS STIMULATION AND IT WAS NOT COVERING THE AREA HE NEEDED. THE PATIENT REPORTEDLY WAS ADMITTED INTO THE INTENSIVE-CARE UNIT FOLLOWING HIS IMPLANT IN 2007, AND HAD "ABOUT 4 EPISODES" OF TACHYCARDIA "SINCE IMPLANT." IT WAS STATED THAT THE CARDIOLOGIST DID A "FULL WORK OUT" OF HIS HEART, BUT WAS UNABLE TO FIND THE CAUSE OF HIS TACHYCARDIA. IT WAS NOTED THAT TWO MONTHS PRIOR TO THIS REPORT, THE PATIENT EXPERIENCED CHEST PAIN, WAS HOSPITALIZED, AND FOUND OUT HE HAD VENTRICULAR TACHYCARDIA. THE PATIENT REPORTEDLY HAD A LOOP RECORDER IMPLANTED "LAST THURSDAY" PRIOR TO THE REPORT. IT WAS ALSO NOTED THAT THE PATIENT HAD "BLOCK OUTS ABOUT 7 - 8 YEARS AGO." ADDITIONAL INFORMATION AS REQUESTED AND IF RECEIVED, A SUPPLEMENTAL REPORT WILL BE SENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 RESTORE ADVANCED STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF LGW MEDTRONIC MED REL MEDTRONIC PUERTO RICO 37713

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization