MAUDE Adverse Event Report: SORIN GROUP ITALIA S.R.L. - CRM FACILITY PLATINIUM; DEFIBRILLATOR, IMPLANTABLE, DUAL-CHAMBER

Model Number PLATINIUM DR 1510

Device Problem Wireless Communication Problem (3283)

Patient Problem No Patient Involvement (2645)

Event Date 11/10/2016

Event Type  malfunction  

Event Description

Reportedly, on (b)(6) 2016, the subject icd was not implanted because rf communication was not possible.The inductive programming head was placed on the device (inside its box) and the rf communication had started.Without listening to the acoustic alarm, the inductive programming head was removed in order to establish the rf communication, but communication was not successful.Additional tests were performed later in the main office.The issue was still present at first attempt.At the second attempt, rf communication was properly established.

Manufacturer Narrative

Please refer to the attached analysis report.

Event Description

Reportedly, on (b)(6) 2016, the subject icd was not implanted because rf communication was not possible.The inductive programming head was placed on the device (inside its box) and the rf communication had started.Without listening to the acoustic alarm, the inductive programming head was removed in order to establish the rf communication, but communication was not successful.Additional tests were performed later in the main office.The issue was still present at first attempt.At the second attempt, rf communication was properly established.

• Brand Name: PLATINIUM
• Type of Device: DEFIBRILLATOR, IMPLANTABLE, DUAL-CHAMBER
• 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: 6147318
• MDR Text Key: 61885623
• Report Number: 1000165971-2016-00790
• Device Sequence Number: 1
• Product Code: MRM
• Combination Product (y/n): N
• Reporter Country Code: SP
• PMA/PMN Number: PP980049
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 11/11/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/06/2016
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 02/06/2018
• Device Model Number: PLATINIUM DR 1510
• Device Catalogue Number: PLATINIUM DR 1510
• Device Lot Number: S0199
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Distributor Facility Aware Date: 11/11/2016
• Event Location: Hospital
• Date Manufacturer Received: 12/19/2016
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 07/06/2016
• 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