BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    RESTORE ADVANCED

    MDR report key: 2539417 · Received April 18, 2012

    Report

    Report Number
    3004209178-2012-02448
    Event Type
    Malfunction
    Date Received
    April 18, 2012
    Report Date
    March 26, 2012
    Manufacturer
    MDT PUERTO RICO OPERATIONS CO
    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

    (B)(4).

    Additional Manufacturer Narrative · 1

    PRODUCT ID 748925, SERIAL# (B)(4), IMPLANTED: (B)(6) 2003, PRODUCT TYP EXTENSION PRODUCT ID 7425, SERIAL# (B)(4), IMPLANTED: (B)(6) 2003, EXPLANTED: (B)(6) 2012, PRODUCT TYP IMPLANTABLE NEUROSTIMULATOR PRODUCT ID 74001, LOT# N251452, IMPLANTED: (B)(6) 2012, EXPLANTED: PRODUCT TYP ADAPTER PRODUCT ID 389233, LOT# J0322274V, IMPLANTED: (B)(6) 2003, EXPLANTED: PRODUCT TYP LEAD PRODUCT ID 37754, SERIAL# (B)(4), PRODUCT TYP RECHARGER PRODUCT ID 37744, SERIAL# (B)(4), PRODUCT TYP PROGRAMMER. (B)(4).

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION RECEIVED REPORTED THAT THE PATIENT EXPERIENCED A BURNING SENSATION AND A SHOCKING OR JOLTING SENSATION, BEGINNING SEVERAL DAYS AFTER THE REPLACEMENT. STIMULATION COVERAGE WAS GOOD AND IMPEDANCE MEASUREMENTS WERE NORMAL POST-OPERATIVELY. IT WAS REPORTED THAT FURTHER IMPEDANCE TESTS WERE WITHIN RANGE AND REPROGRAMMING WAS SUCCESSFUL IN CAPTURING THE CORRECT AREAS FOR PAIN AND THE PATIENT LEFT SATISFIED.

    Description of Event or Problem · 1

    IT WAS REPORTED THERE WAS A STIMULATOR REPLACEMENT ON (B)(6) 2012 AS THE PREVIOUS STIMULATOR HAD REACHED END OF SERVICE. FOLLOWING THE REPLACEMENT, THERE WAS AN ISSUE IN REGARDS TO IMPEDANCE: THERE WAS A READING >40000 OHMS. IMPEDANCES WERE CHECKED INTRA-OP AND WERE WITHIN NORMAL RANGE. POST-OP IMPEDANCES WERE >40,000. THE LEAD CONFIGURATION WAS CHANGED FROM 0-3 TO 8-11 AND THIS RESOLVED THE ISSUE. IMPEDANCE READINGS WERE IN RANGE OF 671-676.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 RESTORE ADVANCED STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF LGW MDT PUERTO RICO OPERATIONS CO 37713

    Patients

    Seq Age Sex Outcome Treatment
    1