BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PRIMEADVANCED

    MDR report key: 3871982 · Received June 13, 2014

    Report

    Report Number
    3004209178-2014-11550
    Event Type
    Malfunction
    Date Received
    June 13, 2014
    Date of Event
    March 7, 2014
    Report Date
    May 22, 2014
    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

    METHOD: ANALYSIS OF THE IMPLANTABLE NEUROSTIMULATOR (SERIAL # (B)(4)) FOUND NO ANOMALY.

    Additional Manufacturer Narrative · 1

    CONCOMITANT PRODUCTS: PRODUCT ID 3888Q33, LOT# VA07LHQ, IMPLANTED: (B)(6) 2014, PRODUCT TYPE LEAD, PRODUCT ID 3888Q45, LOT# VA07LH5, IMPLANTED: (B)(6) 2014, PRODUCT TYPE LEAD; PRODUCT ID 3888Q45, LOT# VA07N8C, IMPLANTED: (B)(6) 2014, PRODUCT TYPE LEAD; PRODUCT ID 3708220, SERIAL# (B)(4), IMPLANTED: (B)(6) 2014, PRODUCT TYPE EXTENSION; PRODUCT ID 3708220, SERIAL# (B)(4), IMPLANTED: (B)(6) 2014, PRODUCT TYPE EXTENSION; PRODUCT ID 3888Q33, LOT# VA07LHQ, IMPLANTED: (B)(6) 2014, PRODUCT TYPE LEAD. (B)(4).

    Additional Manufacturer Narrative · 1

    CONCOMITANT MEDICAL PRODUCTS: PRODUCT ID 3888Q33, LOT# VA07LHQ, IMPLANTED: (B)(6) 2014, PRODUCT TYPE: LEAD. PRODUCT ID 3888Q45, LOT# VA07LH5, IMPLANTED: (B)(6) 2014, PRODUCT TYPE: LEAD. PRODUCT ID 3888Q45, LOT# VA07N8C, IMPLANTED: (B)(6) 2014, PRODUCT TYPE: LEAD. PRODUCT ID 3708220, SERIAL# (B)(4), IMPLANTED: (B)(6) 2014, PRODUCT TYPE: EXTENSION. PRODUCT ID 3708220, SERIAL# (B)(4), IMPLANTED: (B)(6) 2014, PRODUCT TYPE: EXTENSION. PRODUCT ID 3888Q33, LOT# VA07LHQ, IMPLANTED: (B)(6) 2014, PRODUCT TYPE: LEAD. PRODUCT ID 3550-39, LOT# N332917, PRODUCT TYPE: ACCESSORY. PRODUCT ID 3550-39, LOT# N332917, PRODUCT TYPE: ACCESSORY. PRODUCT ID 3550-39, LOT# N332917, PRODUCT TYPE: ACCESSORY. PRODUCT ID 3550-39, LOT# N332917, PRODUCT TYPE: ACCESSORY. (B)(4). ANALYSIS RESULTS NOT AVAILABLE AT THE TIME OF REPORT. A SUPPLEMENTAL MDR WILL BE SUBMITTED ONCE ANALYSIS RESULTS ARE AVAILABLE.

    Additional Manufacturer Narrative · 1

    IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Description of Event or Problem · 1

    IT WAS REPORTED THE PATIENT HAD HIGH IMPEDANCE ON ALL BIPOLAR PAIRS WITH ELECTRODE 3 AND SOME WITH ELECTRODE 4. NO ACTION HAD BEEN TAKEN AND THE EVENT WAS NOTED AS ONGOING WITH NO FURTHER ACTION. THE EVENT WAS NOT RELATED TO THE IMPLANT PROCEDURE AND NOT APPLICABLE TO THE DEVICE OR THERAPY. THERE WERE NO SIGNS OR SYMPTOMS RELATED TO THE EVENT.

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION RECEIVED REPORTED THAT THE DEVICE AND COMPONENT WERE EXPLANTED PER PATIENT REQUEST. THERE WAS INSUFFICIENT PAIN RELIEF. THERE WAS NO PATIENT INJURY. THE PATIENT RECOVERED WITHOUT SEQUELAE.

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION RECEIVED FROM THE HEALTHCARE PROFESSIONAL (HCP) OF A CLINICAL STUDY REPORTED THAT THE OUTCOME WAS RESOLVED WITHOUT SEQUELAE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    351070 PRIMEADVANCED STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF LGW MEDTRONIC MED REL MEDTRONIC PUERTO RICO 37702

    Patients

    Seq Age Sex Outcome Treatment
    1 00049 YR Required Intervention