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

Model Number PLATINIUM DR 1540

Device Problems Failure to Deliver Shock/Stimulation (1133); Low impedance (2285); Data Problem (3196)

Patient Problem No Information (3190)

Event Date 10/18/2019

Event Type  Injury  

Manufacturer Narrative

Reportedly, a re-intervention was performed to implant a new ventricular lead, which was connected to the subject icd.The previous lead was capped and remained inside the patient's body.

Event Description

Reportedly, during the follow-up performed on (b)(6) 2019, messages stating that the shock impedance was low and the defibrillation system was potentially infective and that the maximum shock energy was ineffective were displayed.In addition, the impedances curves were abnormal.It was observed that an arrhythmic storm occurred on (b)(6) 2019, but the shocks could not be delivered due to overload.It is suspected that the ventricular tachycardia was stopped by the shock delivery.However, as the signal was not saturated after the shock, the physician doubted the shock effectiveness.

• 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: laura ouaki ; parc d'affaires noveos 4 avenue réaumur; .; clamart 92140 ; FR 92140 ; 0146013429
• MDR Report Key: 9290848
• MDR Text Key: 165445008
• Report Number: 1000165971-2019-00619
• Device Sequence Number: 1
• Product Code: MRM
• UDI-Device Identifier: 08031527014401
• UDI-Public: (01)08031527014401(11)190110(17)200810
• 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: 11/07/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 08/10/2020
• Device Model Number: PLATINIUM DR 1540
• Device Catalogue Number: PLATINIUM DR 1540
• Device Lot Number: S0348
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Distributor Facility Aware Date: 10/19/2019
• Initial Date Manufacturer Received: 10/19/2019
• Initial Date FDA Received: 11/07/2019
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 01/10/2019
• 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
• Patient Outcome(s): Hospitalization; Required Intervention