BEUDAMED
    FDA Adverse Event Injury Summary report: N

    RESTORE PRIME ADVANCED

    MDR report key: 2231131 · Received August 26, 2011

    Report

    Report Number
    3004209178-2011-06954
    Event Type
    Injury
    Date Received
    August 26, 2011
    Date of Event
    August 16, 2011
    Report Date
    August 16, 2011
    Manufacturer
    MDT PUERTO RICO OPERATIONS CO., JUNCOS
    Product Code
    LGW
    PMA / PMN Number
    P840001
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MN, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    OUT-OF-RANGE IMPEDANCE VALUES WERE REPORTED. IT WAS THOUGHT THAT THE OUT OF RANGE VALUES MIGHT HAVE BEEN DUE TO THE POSSIBILITY THAT ONLY ONE OCTAD AND ONE QUAD WERE IMPLANTED, AS THE REPRESENTATIVE STATED THAT #12-15 WERE OUT OF RANGE. IT WAS REPORTED THAT THE BATTERY LEVEL WAS 2.9 AND THE PT HAD A FEW MORE YEARS REMAINING. ADDITIONAL INFO RECEIVED REPORTED THAT THE HCP WANTED TO REPLACE THE IMPLANTABLE NEUROSTIMULATOR DUE TO THE END OF BATTERY LIFE BASED ON USAGE. THE PT WAS RECEIVING STIMULATION BUT IT WAS NOT COVERING THE PAIN. REPROGRAMMING AND IMPEDANCE CHECKS COULD NOT FIX THE PROBLEM. THE PT RECEIVED A NEW IMPLANTABLE PULSE GENERATOR AND LEADS. THE PT RECEIVED GOOD COVERAGE AND PAIN REDUCTION. ADDITIONAL INFO HAS BEEN REQUESTED, BUT WAS NOT AVAILABLE AS OF THE DATE OF THIS REPORT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 RESTORE PRIME ADVANCED LGW MDT PUERTO RICO OPERATIONS CO., JUNCOS 37702 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 63 YR Required Intervention EXTENSION: MODEL 37081, LOT# NJB005057V| LEAD: MODEL 3778, LOT# V022804003| LOT# NKL701369H| EXPLANTED:| IMPLANTED:| EXPLANTED:| IMPLANTED:| PROGRAMMER: MODEL 37742, LOT# NJD043038N| LEAD: MODEL 3778, LOT# V022804002| IMPLANTED:| EXTENSION: MODEL 37081, LOT# NJB006008V| EXPLANTED:| IMPLANTED:| EXTENSION: MODEL 37083, LOT# NKC012895N| EXPLANTED:| IMPLANTED:| LEAD: MODEL 3778, LOT# V027479006| EXPLANTED:| IMPLANTED:| EXPLANTED:| IMPLANTED:| EXPLANTED:| PROGRAMMER: MODEL 37742, LOT# NJD046218N| IMPLANTABLE NEURO STIMULATOR: MODEL 37702,