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

Model Number PARADYM RF DR 9550

Device Problem Failure to Transmit Record (1521)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 12/16/2013

Event Type  malfunction  

Event Description

The remote report of (b)(6) 2013 showed yellow warning for lead and coil but leads impedances were within normal range.An explanation is required.

Manufacturer Narrative

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 ave reaumur; clamart cedex 92140 ; FR 92140 ; 46013687
• MDR Report Key: 3775266
• MDR Text Key: 4434192
• Report Number: 1000165971-2014-00146
• Device Sequence Number: 1
• Product Code: MRM
• Combination Product (y/n): N
• Reporter Country Code: IT
• PMA/PMN Number: P980049
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 01/24/2014,01/09/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 05/04/2014
• Device Model Number: PARADYM RF DR 9550
• Device Catalogue Number: PARADYM RF DR 9550
• Device Lot Number: 2700
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Event Location: Hospital
• Initial Date Manufacturer Received: 01/09/2014
• Initial Date FDA Received: 04/25/2014
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 04/01/2013
• 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