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

Model Number PLATINIUM VR 1240

Device Problem Reset Problem (3019)

Patient Problem No Information (3190)

Event Date 01/07/2018

Event Type  malfunction  

Event Description

Reportedly, the device was interrogated on (b)(6) 2018.Upon re-interrogation on (b)(6) 2018, several warnings were displayed, stating that: a reset occurred on (b)(6) 2018, the device had been initialized one time since implantation, and high lead impedance (saturated at 3000 ohms) was measured.Repeated measurements showed a stable lead impedance around 500 ohms.The patient underwent an ablation procedure later on (b)(6) 2018.On (b)(6) 2018, normal impedance was measured.

Manufacturer Narrative

(b)(4).

Event Description

Reportedly, the device was interrogated on (b)(6) 2018.Upon re-interrogation on (b)(6) 2018, several warnings were displayed, stating that: a reset occurred on (b)(6) 2018, the device had been initialized one time since implantation, and high lead impedance (saturated at 3000 ohms) was measured.Repeated measurements showed a stable lead impedance around 500 ohms.The patient underwent an ablation procedure later on (b)(6) 2018.On (b)(6) 2018, normal impedance was measured.

Manufacturer Narrative

Preliminary analysis confirmed that a reset occurred during the follow-up performed on 5 january 2018.This reset was caused by an abnormal decrease of the device internal supply.Normal behavior was restored after the reset.There is no suspicion of a ventricular lead issue or a lead-icd connection issue at ventricular level.

Event Description

Reportedly, the device was interrogated on (b)(6) 2018.Upon re-interrogation on (b)(6) 2018, several warnings were displayed, stating that: a reset occurred on (b)(6) 2018, the device had been initialized one time since implantation, and high lead impedance (saturated at 3000 ohms) was measured.Repeated measurements showed a stable lead impedance around 500 ohms.The patient underwent an ablation procedure later on (b)(6) 2018.On (b)(6) 2018, normal impedance was measured.

• 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
• MDR Report Key: 7237136
• MDR Text Key: 99097872
• Report Number: 1000165971-2018-00134
• Device Sequence Number: 1
• Product Code: MRM
• UDI-Device Identifier: 08031527014357
• UDI-Public: (01)08031527014357(11)151104(17)170604
• Combination Product (y/n): N
• PMA/PMN Number: P980049
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional
• Type of Report: Initial,Followup,Followup
• Report Date: 01/11/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/02/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 06/04/2017
• Device Model Number: PLATINIUM VR 1240
• Device Catalogue Number: PLATINIUM VR 1240
• Device Lot Number: S0126
• Was Device Available for Evaluation?: No
• Distributor Facility Aware Date: 01/11/2018
• Event Location: Hospital
• Date Manufacturer Received: 03/20/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1