BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PRIMEADVANCED

    MDR report key: 3914117 · Received July 3, 2014

    Report

    Report Number
    3004209178-2014-12542
    Event Type
    Injury
    Date Received
    July 3, 2014
    Date of Event
    July 19, 2013
    Report Date
    July 19, 2013
    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
    CA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    PRODUCT ID: 3708140, SERIAL# (B)(4), IMPLANTED: (B)(6) 2008, PRODUCT TYPE: EXTENSION. PRODUCT ID: 3708140, SERIAL# (B)(4), IMPLANTED: (B)(6) 2008, PRODUCT TYPE: EXTENSION. PRODUCT ID: 37742, SERIAL# (B)(4), IMPLANTED: (B)(6) 2008, PRODUCT TYPE: PROGRAMMER. PATIENT PRODUCT ID: 39565-30, SERIAL# (B)(4), IMPLANTED: (B)(6) 2008, PRODUCT TYPE: LEAD. (B)(4).

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THE PATIENT WAS NOT FEELING STIMULATION IN THEIR BACK AND A BROKEN LEAD WAS SUSPECTED. IT WAS NOTED THE PATIENT MET WITH A MANUFACTURING REPRESENTATIVE ON (B)(6) 2013. THE REPORTER STATED THEY WERE DUE FOR A REPLACEMENT BUT WORKMAN¿S COMP WAS REQUIRING DOCUMENTATION OF THAT FACT THE LEAD WAS BROKEN. ADDITIONAL INFORMATION RECEIVED REPORTED THE PATIENT SAW THEIR HEALTHCARE PROFESSIONAL (HCP) AND A MANUFACTURING REPRESENTATIVE APPROXIMATELY ONE YEAR AGO. IT WAS NOTED THE PATIENT MOVED OUT OF (B)(6) TWO YEARS AGO AND THEY CURRENTLY RESIDE IN (B)(6). ADDITIONAL INFORMATION RECEIVED REPORTED THE PATIENT SAW THE HCP ON (B)(6) 2014. THE REPORTER STATED A REQUEST BY THE PATIENT HAD BEEN MADE TO HAVE A MANUFACTURING REPRESENTATIVE AT THE APPOINTMENT. THE REPORTER FURTHER STATED THAT THEY COULD NOT TELL IF A MANUFACTURING REPRESENTATIVE WAS AT THE APPOINTMENT BASED ON THE APPOINTMENT NOTES. ADDITIONAL INFORMATION RECEIVED REPORTED THE MANUFACTURING REPRESENTATIVE MET WITH THE PATIENT ON (B)(4) 2014 AND CHECKED THEIR DEVICE. IT WAS NOTED THE PATIENT HAD A PADDLE LEAD AND THE UPPER CONTACTS WERE SHOWING HIGH IMPEDANCES. IT WAS FURTHER NOTED THE PATIENT DID NOT HAVE COVERAGE FROM THE UPPER CONTACTS. THE REPORTER STATED THIS WAS THE FIRST TIME THEY HAD MET WITH PATIENT. ADDITIONAL INFORMATION WAS REQUESTED, BUT WAS NOT AVAILABLE AS OF THE DATE OF THIS REPORT.

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION RECEIVED REPORTED THAT THE ELECTRODE IMPEDANCES ON ELECTRODES 8-15 WERE GREATER THAN 10,000 OHMS. IT WAS NOTED THAT THE MANUFACTURING REPRESENTATIVE TRIED TO USE THESE ELECTRODES WITH NO STIMULATION FELT AT ANY AMPLITUDE LEVEL. IT WAS NOTED THAT THIS WAS EXPECTED WITH HIGH IMPEDANCES. IT WAS NOTED THAT THE PATIENT HAD A PADDLE LEAD, WHICH HAD A TRIPLE CONFIGURATION. IT WAS NOTED THAT THE ELECTRODES 3-15 WERE ON THE BOTTOM OF THE MIDDLE COLUMN AND ON THE RIGHT SIDE. IT WAS NOTED THAT THE MANUFACTURING REPRESENTATIVE HAD A LOT OF TROUBLE GETTING THE RIGHT SIDE COVERAGE, BUT ALSO HAD TROUBLE GETTING COVERAGE UP INTO THE HIP OR BUTTOCK AREA AND LOW BACK. IT WAS NOTED THAT THE MANUFACTURING REPRESENTATIVE WAS UNSURE IF THE PADDLE MOVED OR IF THE 8-15 ELECTRODES WERE PREVENTING HIM FROM BEING ABLE TO GUARD THE DORSAL ROOTS AND DRIVE THE STIMULATION LOWER TO GET THE LOW BACK. IT WAS NOTED THAT THE PATIENT ALSO HAD EXTENSIONS, SO THERE WERE MULTIPLE CONNECTION POINTS AND POSSIBLY 3 INCISIONS WHERE THE CONNECTION MAY HAVE BEEN POOR, CAUSING THE HIGH IMPEDANCES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    391453 PRIMEADVANCED STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF LGW MEDTRONIC MED REL MEDTRONIC PUERTO RICO 37702

    Patients

    Seq Age Sex Outcome Treatment
    1 00054 YR Required Intervention