BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PRIMEADVANCED

    MDR report key: 2671363 · Received July 26, 2012

    Report

    Report Number
    3004209178-2012-06125
    Event Type
    Injury
    Date Received
    July 26, 2012
    Report Date
    June 28, 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
    NJ, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    PRODUCT ID 3778-60, LOT# SERIAL# (B)(4), 1IMPLANTED: (B)(6) 2008, EXPLANTED: PRODUCT TYPE LEAD. PRODUCT ID 37742, LOT# SERIAL# (B)(4), IMPLANTED: (B)(6) 2008, EXPLANTED: PRODUCT TYPE PROGRAMMER, PATIENT PRODUCT ID 3550-29, LOT# N130238, SERIAL# IMPLANTED: (B)(6) 2008, EXPLANTED: PRODUCT TYPE ACCESSORY. (B)(4).

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT FOLLOWING THE PATIENT'S IMPLANT IN 2008, THE INTERNAL NEUROSTIMULATOR (INS) STARTED PROTRUDING. THE PATIENT STATED THAT "IT GOT WORSE AND WORSE" AND THAT SHE FELT LIKE IT WAS "GOING TO BURST THROUGH THE SKIN IF SHE MOVED". THE PATIENT FURTHER STATED THAT HER PHYSICIAN DID NOT ADDRESS THE ISSUE. IT WAS NOTED THAT THE PATIENT HAD THE DEVICE EXPLANTED IN 2012 AND REPLACED WITH A SMALLER UNIT. THE PATIENT OUTCOME WAS NOT PROVIDED.

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION STATED THE PATIENT FELT "PAIN AT SITE OF PULSE GENERATOR INSERTION." IMPEDANCE TESTING SHOWED NO ABNORMAL IMPEDANCES AND THE PATIENT RECOVERED WITHOUT INJURY.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention