BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PRIMEADVANCED

    MDR report key: 2863122 · Received December 10, 2012

    Report

    Report Number
    3004209178-2012-11284
    Event Type
    Injury
    Date Received
    December 10, 2012
    Report Date
    November 13, 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
    MN, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    PRODUCT ID, 3778-45 LOT# SERIAL# (B)(4), IMPLANTED: 2008 (B)(6), PRODUCT TYPE LEAD PRODUCT ID, 3778-45 LOT# SERIAL# (B)(4), IMPLANTED: 2008 (B)(6), PRODUCT TYPE LEAD PRODUCT ID, 37743 LOT# SERIAL# (B)(4), PRODUCT TYPE PROGRAMMER, PATIENT PRODUCT ID, 3708140 LOT# SERIAL# (B)(4), IMPLANTED: 2008 (B)(6), PRODUCT TYPE EXTENSION PRODUCT ID, 3708140 LOT# SERIAL# (B)(4), IMPLANTED: 2008 (B)(6), PRODUCT TYPE EXTENSION. (B)(4).

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT HAD A SPINAL FUSION IN MAY AND THE HEALTH CARE PROFESSIONAL (HCP) ACCIDENTLY "NICKED" THE LEADS. THE PATIENT'S DEVICE WAS ON, BUT SHE WAS NOT FEELING STIMULATION. LEAD REPLACEMENT WAS MENTIONED. ADDITIONAL INFORMATION RECEIVED THE FOLLOWING DAY REPORTED THAT THE HCP STATED, THE LEADS WERE CUT DURING SURGERY. NO IMPEDANCE TESTS WERE DONE AND NO X-RAYS WERE TAKEN, BUT WERE TO BE DONE ON THE DAY OF THE REVISION. THE LEADS AND DEVICE WERE PLANNED TO BE REPLACED, TENTATIVELY IN (B)(6). A PATIENT OUTCOME WAS UNAVAILABLE, AS SURGERY HAD NOT TAKEN PLACE YET.

    Description of Event or Problem · 1

    FOLLOW UP REPORTED THE PATIENT WAS SCHEDULED FOR SURGERY ON (B)(6) 2013, THIS WAS ALSO CONFIRMED BY THE MANUFACTURER'S DEVICE REGISTRATION SYSTEM. FURTHER FOLLOW UP REPORTED ONE OF THE PATIENT'S LEADS WERE CUT AND REMOVED BY THE SURGEON AT THE TIME OF A SPINAL FUSION. THE REMAINING LEAD WAS CUT BY THE HEALTH CARE PROVIDER AND REMOVED OF AND DISPOSED OF. TWO NEW LEADS WERE PLACED AND HOOKED UP TO THE EXTENSIONS AND THE STIMULATOR REMAINED IN PLACE. THE PATIENT WAS GETTING GOOD STIMULATION POST OPERATIVELY. IT WAS NOTED THE PATIENT WAS DOING 'WELL.'

    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