BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PRIMEADVANCED

    MDR report key: 3881312 · Received June 18, 2014

    Report

    Report Number
    3004209178-2014-11758
    Event Type
    Malfunction
    Date Received
    June 18, 2014
    Date of Event
    March 13, 2014
    Report Date
    May 27, 2014
    Manufacturer
    MEDTRONIC MED REL MEDTRONIC PUERTO RICO
    Product Code
    LGW
    PMA / PMN Number
    P840001
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AZ, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    UPON RETURN OF THE IMPLANTABLE NEUROSTIMULATOR (INS) ANALYSIS FOUND NO ANOMALIES. THE INS PASSED ALL FUNCTIONAL TESTING IN THE LABORATORY. NO ANOMALIES WERE IDENTIFIED. THERE WAS GOOD STABLE OUTPUT ON ALL ELECTRODES.

    Additional Manufacturer Narrative · 1

    CONCOMITANT MEDICAL PRODUCTS: PRODUCT ID 3777Q45, SERIAL# (B)(4), IMPLANTED: (B)(6) 2014, PRODUCT TYPE: LEAD; PRODUCT ID 3777Q45, SERIAL# (B)(4), IMPLANTED: (B)(6) 2014, PRODUCT TYPE: LEAD. (B)(4).

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION RECEIVED REPORTED THAT THE OUTCOME WAS RESOLVED WITHOUT SEQUELAE ON (B)(6) 2014.

    Description of Event or Problem · 1

    IT WAS REPORTED THERE WERE IMPEDANCES GREATER THAN 10,000 OHMS ON ELECTRODE 7. NO SIGNS OR SYMPTOMS WERE REPORTED AND NO ACTION HAD BEEN TAKEN. THE EVENT WAS ONGOING AND NOTED AS NOT RELATED TO IMPLANT PROCEDURE AND NOT APPLICABLE TO DEVICE OR THERAPY.

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION RECEIVED FROM THE HEALTHCARE PROFESSIONAL (HCP) OF A CLINICAL STUDY REPORTED THAT THE DEVICE WAS EXPLANTED PER PATIENT REQUEST AT STUDY CLOSURE. THE OUTCOME WAS RECOVERED WITHOUT SEQUELAE. THE CAUSE OF THE HIGH IMPEDANCE WAS NOT DETERMINED.

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION RECEIVED FROM THE HEALTHCARE PROFESSIONAL (HCP) OF A CLINICAL STUDY REPORTED THAT THE PATIENT DID NOT HAVE A CLINICALLY UNDESIRABLE EXPERIENCE. THE DEVICE DEFICIENCY WAS THAT ELECTRODE #9 HAD IMPEDANCES GREATER THAN 10,000 OHMS. THE OUTCOME WAS ONGOING WITH NO FURTHER ACTIONS NEEDED. INTERVENTIONS INCLUDED REPROGRAMMING. DIAGNOSTIC METHODS INCLUDED DEVICE INTERROGATION WHICH SHOWED THAT ELECTRODE 9 IMPEDANCES WERE GREATER THAN 10,000 OHMS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    357010 PRIMEADVANCED STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF LGW MEDTRONIC MED REL MEDTRONIC PUERTO RICO 37702

    Patients

    Seq Age Sex Outcome Treatment
    1 00036 YR