BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SYNERGY

    MDR report key: 2003784 · Received February 23, 2011

    Report

    Report Number
    3004209178-2011-01384
    Event Type
    Injury
    Date Received
    February 23, 2011
    Date of Event
    January 1, 2007
    Report Date
    December 19, 2019
    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
    OH, US
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Additional Manufacturer Narrative · 1

    PRODUCT ID: 3998, LOT# J0519561V, IMPLANTED: (B)(6) 2005, EXPLANTED: (B)(6) 2014, PRODUCT TYPE: LEAD; PRODUCT ID: 748925, SERIAL# (B)(4), IMPLANTED: (B)(6) 2005, EXPLANTED: (B)(6) 2008, PRODUCT TYPE: EXTENSION; PRODUCT ID: 748925, SERIAL# (B)(4), IMPLANTED: (B)(6) 2005, EXPLANTED: (B)(6) 2008, PRODUCT TYPE: EXTENSION. IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT MENTIONED THE LEAD HAD COME LOOSE BACK IN 2008 AND WAS REVISED. NO FURTHER COMPLICATIONS WERE REPORTED/ANTICIPATED.

    Description of Event or Problem · 1

    IT WAS REPORTED, THERE WAS A SHOCKING OR JOLTING SENSATION AT THE STIMULATOR LOCATION AND AT THE LEAD-EXTENSION CONNECTION LOCATION. THE PATIENT WAS GETTING A SHOCKING SENSATION APPROXIMATELY 2 TIMES A DAY. PALPATION DID NOT BRING ON THE SHOCKING SENSATION, AND GENTLE PALPATION PRODUCED NO SENSATION. PALPATION THAT INVOLVED "PRESSING HARD" DID HURT THE PATIENT. THE HEALTH CARE PROFESSIONAL STATED, THERE WAS OVERSTIMULATION AND THE PATIENT HAD PAIN OR DISCOMFORT. THE IMPEDANCES WERE MEASURED AND THE RESULTS WERE NORMAL. THE PATIENT WAS SCHEDULED TO HAVE AN X-RAY, AND THE RESULTS WERE NOT REPORTED. THE HEALTH CARE PROFESSIONAL STATED THERE WAS A BREAKAGE IN THE LEAD AND ATTRIBUTED THE SHOCKING SENSATION TO THE STIMULATOR AND LEAD. THE STIMULATOR AND LEAD WERE REVISED ON (B)(6) 2008. THE PATIENT HAD NO INJURY AND RECOVERED WITHOUT SEQUELA.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SYNERGY STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF LGW MEDTRONIC MED REL MEDTRONIC PUERTO RICO 7427 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 38 YR Required Intervention LEAD: MODEL 3998, LOT# J0519561V| EXPLANTED:| EXPLANTED:| EXPLANTED:| IMPLANTED:| IMPLANTED:| EXTENSION: MODEL 7489, LOT# NHU084044V| IMPLANTED:| EXTENSION: MODEL 7489, LOT# NHU084045V