BEUDAMED
    FDA Recall Terminated

    Paradym DR Model 8550 and Paradym VR Model 8250, Sterile EO, Manufactured in Italy by Sorin CRM S. r.l., Via Crescentino s.n., 13040 Saluggia(VC) Italy PARADYM DR 8550 and PARADYM VR 8250 are indicated for use in patients who are at high risk of sudden cardiac death due to ventricular tachyarrhythmias and who have experienced one of the following situations: Survival of at least one episode of cardiac arrest (manifested by the loss of consciousness) due to ventricular tachyarrhythmia, recurrent, poorly tolerated sustained ventricular tachycardia (VT).

    Recall: Z-2609-2011 · Initiated May 2, 2011

    Recall

    Recall Number
    Z-2609-2011
    Event Number
    58767
    Firm
    ela Medical Llc
    FEI Number
    2182863
    Product Code
    MRM
    Status
    Terminated
    Root Cause
    Error in labeling
    Initiated
    May 2, 2011
    Posted
    June 22, 2011
    Terminated
    April 26, 2012
    Address
    2905 Northwest Blvd, Ste 40, Plymouth, MN, 55441-2673

    Description

    Paradym DR Model 8550 and Paradym VR Model 8250, Sterile EO, Manufactured in Italy by Sorin CRM S. r.l., Via Crescentino s.n., 13040 Saluggia(VC) Italy PARADYM DR 8550 and PARADYM VR 8250 are indicated for use in patients who are at high risk of sudden cardiac death due to ventricular tachyarrhythmias and who have experienced one of the following situations: Survival of at least one episode of cardiac arrest (manifested by the loss of consciousness) due to ventricular tachyarrhythmia, recurrent, poorly tolerated sustained ventricular tachycardia (VT).

    Reason

    On February 28, 2011, the company discovered that since the beginning of the US commercial distribution of Paradym DR 8550 and Paradym VR 8250 ICDs in October 2010, the devices included an incorrect version of the Patient Booklet. The company determined that there is no risk of adverse event associated with this labeling error.

    Action

    Sorin CRM USA instructed its field representatives on April 27, 2011 via a conference call to attach the correct Patient Booklet (ref. N582,) as an addendum to the device's external packaging, along with a cover letter "Quality Note" dated May 2, 2011 explaining the discrepancy. The field representatives were fedexed the information on May 2, 2011. The letter instructed the Field Representative to attach the correct patient booklet and an addendum, to the outside of the device box. Field Representatives were asked to complete the acknowledgement form by identifying S/N's in which they attached the pouch and their signature of completion and fax the form to 866-500-6096 or e-mail a scanned copy to sorin.ptusa.sorin.com. For questions regarding this recall call 877-663-7674. " For affected units that were already implanted as of April 27, 2011, the patient booklet given to the patient may include information written by the physician or hospital staff that is related to the implanted system (ICD and leads), physician references and patient medications. For this reason and given the fact that the company determined that there is no risk for the patient associated with this labeling error, the company decided to not replace the patient booklet for this population.

    Distribution

    Nationwide Distribution including AL, AZ, AR, CA, CO, CT, FL, GA, IA, MA, MI, MO, MS, NJ, NY, NC, OH, OK, PA, SC,A TN,T X, and WA.

    Quantity

    275