MAUDE Adverse Event Report: SORIN GROUP ITALIA S.R.L. PARADYM

Model Number PARADYM DR 8550

Device Problems Unable to Obtain Readings (1516); Failure to Transmit Record (1521); Device Displays Incorrect Message (2591)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 12/18/2013

Event Type  malfunction  

Event Description

Reportedly, during the f/u performed on (b)(6) 2013, an error message "unable to read file" was displayed.When the device was re-interrogated, the user interface froze (did not react anymore) while accessing to arrhythmia and therapy history.According to the physician, this behaviour was reproduced with another programmer.And explanation is required.

Manufacturer Narrative

(b)(4) 2014.This event concerns a device that was manufactured and used outside the united states.Analysis is pending.

• Brand Name: PARADYM
• Manufacturer (Section D): SORIN GROUP ITALIA S.R.L.; saluggia ; IT
• Manufacturer (Section G): SORIN GROUP ITALIA S.R.L.; via crescentino s.n.; saluggia (vc) 1304 0; IT 13040
• Manufacturer Contact: e vincent ; 4 avenue reaumur; clamart cedex 92140 ; FR 92140 ; 46013687
• MDR Report Key: 3695795
• MDR Text Key: 4291763
• Report Number: 1000165971-2014-00017
• Device Sequence Number: 1
• Product Code: MRM
• Combination Product (y/n): N
• Reporter Country Code: PO
• PMA/PMN Number: P980049
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 01/17/2014,12/23/2013

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/17/2014
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 04/30/2012
• Device Model Number: PARADYM DR 8550
• Device Catalogue Number: PARADYM DR 8550
• Device Lot Number: 2523
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Event Location: Hospital
• Date Manufacturer Received: 12/23/2013
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 03/01/2011
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1