MAUDE Adverse Event Report: SORIN GROUP ITALIA S.R.L. - CRM FACILITY PLATINIUM; DEFIBRILLATOR, AUTOMATIC IMPLANTABLE CARDIOVERTER,WITH CRT-D

Model Number PLATINIUM CRT-D 1711

Device Problem Display or Visual Feedback Problem (1184)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 08/17/2016

Event Type  malfunction  

Event Description

The subject device was implanted on (b)(6) 2016.The subject crt-d was checked on (b)(6) 2016 and rv and svc coil continuity trend curves were properly displayed on the programmer screen.However, when these curves were printed out, abnormally high values were displayed on the printout.The subject crt-d was checked again on (b)(6) 2016 and rv and svc coil continuity trend curves were properly displayed on the programmer screen and on the printout.

Event Description

The subject device was implanted on (b)(6) 2016.The subject crt-d was checked on (b)(6) 2016 and rv and svc coil continuity trend curves were properly displayed on the programmer screen.However, when these curves were printed out, abnormally high values were displayed on the printout.The subject crt-d was checked again on (b)(6) 2016 and rv and svc coil continuity trend curves were properly displayed on the programmer screen and on the printout.

• Brand Name: PLATINIUM
• Type of Device: DEFIBRILLATOR, AUTOMATIC IMPLANTABLE CARDIOVERTER,WITH CRT-D
• Manufacturer (Section D): SORIN GROUP ITALIA S.R.L. - CRM FACILITY; parc d'affaires noveos 4 avenue réaumur; .; clamart 92140 ; FR 92140
• Manufacturer (Section G): SORIN GROUP ITALIA SRL VIA CRESCENTINO 13040 SALUGGIA ITALY; parc d'affaires noveos 4 avenue réaumur; .; clamart 92140 ; FR 92140
• Manufacturer Contact: elodie vincent ; parc d'affaires noveos 4 avenue réaumur; .; clamart 92140 ; FR 92140 ; 0146013665
• MDR Report Key: 5956066
• MDR Text Key: 54941727
• Report Number: 1000165971-2016-00558
• Device Sequence Number: 1
• Product Code: NIK
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: PP060027
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 08/22/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/16/2016
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Physician
• Device Expiration Date: 12/10/2017
• Device Model Number: PLATINIUM CRT-D 1711
• Device Catalogue Number: PLATINIUM CRT-D 1711
• Device Lot Number: S0182
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Distributor Facility Aware Date: 08/22/2016
• Event Location: Hospital
• Date Manufacturer Received: 11/02/2016
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 05/10/2016
• 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