BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SURESCAN

    MDR report key: 3830189 · Received May 23, 2014

    Report

    Report Number
    3004209178-2014-09560
    Event Type
    Malfunction
    Date Received
    May 23, 2014
    Date of Event
    May 2, 2014
    Report Date
    May 2, 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

    CONCOMITANT MEDICAL PRODUCTS: PRODUCT ID: 977A160, SERIAL# (B)(4), IMPLANTED: (B)(6) 2013, PRODUCT TYPE: LEAD. PRODUCT ID: 977A160, SERIAL# (B)(4), PRODUCT TYPE: LEAD. PRODUCT ID: 97740, SERIAL# (B)(4), PRODUCT TYPE: PROGRAMMER, PATIENT. PRODUCT ID: 97754, SERIAL# (B)(4), PRODUCT TYPE: RECHARGER. PRODUCT ID: 977A160, SERIAL# (B)(4), IMPLANTED: (B)(6) 2013, PRODUCT TYPE: LEAD. PRODUCT ID: 977A160, SERIAL# (B)(4), IMPLANTED: (B)(6) 2013, PRODUCT TYPE: LEAD. PRODUCT ID: 977A160, SERIAL# (B)(4), PRODUCT TYPE: LEAD. PRODUCT ID: 977A160, SERIAL# (B)(4), PRODUCT TYPE: LEAD. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THE MANUFACTURER REPRESENTATIVE MET WITH THE PATIENT ON THE DAY OF REPORT FOR PROGRAMMING AND NOTED NO STIMULATION SENSATION ON THE LEFT LEAD. IT WAS REPORTED THE PATIENT HAD NO HEADACHE AND WAS SITTING AT 70 DEGREES. IT WAS FURTHER REPORTED THE CALLER NOTED THE LEFT LEAD WAS GETTING ¿1.1 AND 1.85V AMPLITUDE (BUT WAS ASSUMED THEY MEANT THE RIGHT LEAD)¿. IT WAS REPORTED THE MANUFACTURER REPRESENTATIVE TRIED TO PROGRAM THE LEAD INCORPORATING A ¿U SHAPE DESIGN¿ WITH BOTH LEADS AND AT THIS POINT THE PATIENT REPORTED A SLIGHT HEADACHE. IT WAS REPORTED THE MANUFACTURER REPRESENTATIVE BELIEVED THE LEFT LEAD COULD BE IN THE INTRATHECAL SPACE. **INFORMATION OMITTED PERTAINING TO EVENT (B)(4) ¿ DIFFICULTY ADVANCING LEAD** ADDITIONAL INFORMATION RECEIVED REPORTED NO DIAGNOSTICS WERE PERFORMED, JUST THE POST-OPERATIVE PROGRAMMING. IT WAS REPORTED NO MALFUNCTIONS WERE SEEN OTHER THAN ONLY THE RIGHT SIDE COVERAGE. IT WAS REPORTED THE PATIENT OUTCOME WAS UNKNOWN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    307608 SURESCAN STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF LGW MEDTRONIC MED REL MEDTRONIC PUERTO RICO 97713

    Patients

    Seq Age Sex Outcome Treatment
    1 00061 YR