BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PRIMEADVANCED

    MDR report key: 3030930 · Received April 2, 2013

    Report

    Report Number
    3004209178-2013-04475
    Event Type
    Malfunction
    Date Received
    April 2, 2013
    Report Date
    March 14, 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
    MN, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    REVIEW OF THIS MDR AND/OR ADDITIONAL INFORMATION RECEIVED SHOWS THAT THERE IS NO EVIDENCE TO REASONABLY SUGGEST THAT THE DEVICE IN THIS REPORT HAS MALFUNCTIONED. THEREFORE, THIS EVENT DID NOT AND DOES NOT MEET THE REPORTING REQUIREMENTS STIPULATED IN 21 CFR 803.

    Additional Manufacturer Narrative · 1

    PRODUCT ID 37752, SERIAL# (B)(4), PRODUCT TYPE: RECHARGER. PRODUCT ID 37746, SERIAL# (B)(4), PRODUCT TYPE: PROGRAMMER, PATIENT. PRODUCT ID 39565-65, SERIAL# (B)(4), IMPLANTED: (B)(6) 2010, PRODUCT TYPE: LEAD. (B)(4).

    Additional Manufacturer Narrative · 1

    CONCOMITANT MEDICAL PRODUCTS: PRODUCT ID 37752, SERIAL# (B)(4), PRODUCT TYPE: RECHARGER. PRODUCT ID 37746, SERIAL# (B)(4), PRODUCT TYPE: PROGRAMMER, PATIENT. PRODUCT ID 39565-65, SERIAL# (B)(4), IMPLANTED: (B)(6) 2010, PRODUCT TYPE: LEAD. ADDITIONAL REVIEW OF EVENT WAS PERFORMED, INDICATING THAT THE EVENT IS REPORTABLE. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT HAD BURNING AT THE IMPLANTABLE NEUROSTIMULATOR (INS) POCKET AND IN "OTHER PLACES". THE BURNING OCCURRED FOLLOWING IMPLANTATION OF THE INS. THE PATIENT WAS TO MEET WITH THE MANUFACTURER REPRESENTATIVE IN THE NEXT COUPLE OF WEEKS TO ASSESS THE ISSUE. FOLLOW UP INFORMATION RECEIVED REPORTED THAT THE PATIENT WAS TO MEET WITH THE MANUFACTURER REPRESENTATIVE ON (B)(6) 2013, BUT THEY CANCELED THE APPOINTMENT. NO FURTHER INFORMATION WAS AVAILABLE. ADDITIONAL INFORMATION WAS REQUESTED BUT WAS NOT AVAILABLE AT THE TIME OF THIS REPORT.

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION STATED THE PATIENT WAS ¿DOING OKAY WITH CHARGING HIS BATTERY.¿ IT WAS ALSO NOTED THE PATIENT HAD CANCELED HIS (B)(6) 2013 APPOINTMENT WITH A MANUFACTURER REPRESENTATIVE AND SCHEDULED AN APPOINTMENT TO MEET WITH THEIR PHYSICIAN IN (B)(6) 2013.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT HAD BURNING AT THE IMPLANTABLE NEUROSTIMULATOR (INS) POCKET AND IN "OTHER PLACES". THE BURNING OCCURRED FOLLOWING IMPLANTATION OF THE INS. THE PATIENT WAS TO MEET WITH THE MANUFACTURER REPRESENTATIVE IN THE NEXT COUPLE OF WEEKS TO ASSESS THE ISSUE. FOLLOW UP INFORMATION RECEIVED REPORTED THAT THE PATIENT WAS TO MEET WITH THE MANUFACTURER REPRESENTATIVE ON (B)(6) 2013 BUT THEY CANCELLED THE APPOINTMENT. NO FURTHER INFORMATION WAS AVAILABLE. I WAS SCHEDULED TO MEET WM OTIS (B)(6) AND THE PATIENT CALLED AND CANCELLED. HE IS SUPPOSED TO CONTACT ME TO RESCHEDULE. ADDITIONAL INFORMATION STATED THE PATIENT WAS "DOING OKAY WITH CHARGING HIS BATTERY." IT WAS ALSO NOTED THE PATIENT HAD AN APPOINTMENT TO MEET WITH THEIR PHYSICIAN IN (B)(6) 2013.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    135249 PRIMEADVANCED STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF LGW MEDTRONIC MED REL MEDTRONIC PUERTO RICO 37702

    Patients

    Seq Age Sex Outcome Treatment
    1 00062 YR