BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PRIMEADVANCED

    MDR report key: 2951362 · Received February 9, 2013

    Report

    Report Number
    9614453-2013-00037
    Event Type
    Injury
    Date Received
    February 9, 2013
    Report Date
    January 22, 2013
    Manufacturer
    IPG MFG SWITZERLAND
    Product Code
    LGW
    PMA / PMN Number
    P840001
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A PATIENT'S BATTERY DEPLETED PREMATURELY. THE PATIENT WAS IMPLANTED ON (B)(4) 2012 AND THE BATTERY "WORE OUT PREMATURELY". IT WAS STATED THAT THE IMPEDANCES WERE "GOOD". THE BATTERY WAS GOING TO BE REPLACED WITH A DIFFERENT MODEL. THE PATIENT WAS REPORTED TO BE ALIVE WITH NO ADVERSE EVENT AND NO INJURY. THERE WERE NO PATIENT SYMPTOMS RELATED TO THIS EVENT. NO FURTHER INFORMATION WAS PROVIDED. IF MORE INFORMATION IS RECEIVED, A FOLLOW UP REPORT WILL BE SENT.

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION INDICATED THAT THE IMPLANTABLE NEUROSTIMULATOR (INS) HAD THE FOLLOWING SETTINGS: A1 ELECTRODES 0- 1- 2- 3+ 450 MICROSECONDS 130 HZ 6.1 V A2 ELECTRODES 4- 5- 6- 7+ 450 MICROSECONDS 130 HZ 6 V THE BATTERY LONGEVITY ESTIMATE YIELDED 2 MONTHS. THE INS WAS EXPLANTED AND REPLACED. THE EXTENSIONS WERE NOT CHANGED. IT WAS ALSO NOTED THAT THE PATIENT HAD A PROGRAMMER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    57505 PRIMEADVANCED STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF LGW IPG MFG SWITZERLAND 37702

    Patients

    Seq Age Sex Outcome Treatment
    1 00060 YR Required Intervention