BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PRIMEADVANCED

    MDR report key: 2904265 · Received January 9, 2013

    Report

    Report Number
    3004209178-2013-00355
    Event Type
    Injury
    Date Received
    January 9, 2013
    Report Date
    December 17, 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
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    FINAL ANALYSIS OF THE IMPLANTABLE NEUROSTIMULATOR REVEALED 'NO ANOMALY.' FINAL ANALYSIS OF LEAD 1 ((B)(4)) REVEALED THAT 'ALL CONDUCTORS WERE BROKEN 21 CM FROM THE DISTAL END.' FINAL ANALYSIS OF LEAD 2 ((B)(4)) REVEALED THAT 'ALL CONDUCTORS WERE BROKEN 20.5 CM FROM THE DISTAL END.' FINAL ANALYSIS OF BOTH EXTENSIONS REVEALED THAT BOTH HAD BEEN 'CUT THROUGH' AND 'SEGMENTED.' FINAL ANALYSIS OF BOTH ANCHORS REVEALED THEY BOTH HAD 'CUT SILICONE.'

    Additional Manufacturer Narrative · 1

    CONCOMITANT MEDICAL PRODUCTS: PRODUCT ID 3778-45, SERIAL# (B)(4), IMPLANTED: (B)(6) 2010, EXPLANTED: (B)(6) 2012. PRODUCT TYPE: LEAD: PRODUCT ID 3778-45, SERIAL# (B)(4), IMPLANTED: (B)(6) 2010, EXPLANTED: (B)(6) 2012. PRODUCT TYPE: LEAD: PRODUCT ID 37743, SERIAL# (B)(4). PRODUCT TYPE: PROGRAMMER, PATIENT: PRODUCT ID 3708140, SERIAL# (B)(4), IMPLANTED: (B)(6) 2010, EXPLANTED: (B)(6) 2012. PRODUCT TYPE: EXTENSION: PRODUCT ID 3708140, SERIAL# (B)(4), IMPLANTED: (B)(6) 2010, EXPLANTED: (B)(6) 2012. PRODUCT TYPE: EXTENSION: PRODUCT ID 3550-39. PRODUCT TYPE: ACCESSORY: PRODUCT ID 3550-39. PRODUCT TYPE: ACCESSORY. (B)(4). ANALYSIS RESULTS WERE NOT AVAILABLE AS OF THE DATE OF THIS REPORT. A FOLLOW-UP REPORT WILL BE SUBMITTED WHEN ANALYSIS IS COMPLETE.

    Additional Manufacturer Narrative · 1

    CORRECTED INFORMATION NO EVAL EXPLAIN. IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION WAS RECEIVED WHICH REPORTED THAT THE PATIENT HAD HAD A 'COUPLE' OF FALLS AFTER WHICH THE PATIENT NOTICED A CHANGE IN STIMULATION. TELEMETRY STRIPS SHOWED IMPEDANCES WERE OUT OF RANGE ON ALL ELECTRODES; GREATER THAN 10,000 OHMS, AS REPORTED PREVIOUSLY. THE SERVICE LIFE OF THE IMPLANTABLE NEUROSTIMULATOR (INS) WAS INDICATED TO HAVE BEEN OK, WITH LIFE TIME HOURS USED OF 5,603. THE PATIENT RECOVERED WITHOUT SEQUELA FROM THE REVISION.

    Description of Event or Problem · 1

    IT WAS REPORTED THE PATIENT'S DEVICE WAS REPLACED DUE TO IMPEDANCES GREATER THAN 10,000 OHMS. IT WAS ALSO NOTED THEY WERE UNSURE OF THE "LIFE REMAINING IN THE STIMULATOR." IT WAS NOTED THE PATIENT CHOSE A RECHARGEABLE DEVICE. THE PATIENT EXPERIENCED INEFFECTIVE STIMULATION TO LOW BACK AND LEGS. IT WAS NOTED THERE WAS NO INJURY OR ADVERSE EVENT TO THE PATIENT. ADDITIONAL INFORMATION HAS BEEN REQUESTED BUT WAS NOT AVAILABLE AS OF THE DATE OF THIS REPORT; A FOLLOW-UP REPORT WILL BE SENT IF INFORMATION BECOMES AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    11702 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