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

Model Number PLATINIUM DR 1510

Device Problem Reset Problem (3019)

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

Event Date 04/20/2017

Event Type  Injury  

Event Description

Reportedly, at interrogation before implantation session the session was left open and the programmer showed the manager screen for unknown reason.The following interrogation before implantation showed shocks on but this has not been noticed.Device has been implanted in this status.Device has been shown a reset during follow-up after day of implantation and shock counter showed 4 shocks during implantation procedure (not observed by the physician).In addition, a warning message was displayed saying that last shock impedance was above 150 ohms after reset.Preliminary analysis showed that the reported behavior was most probably due to crosstalk between the icd and another device during interrogation of the device (before implantation).

Manufacturer Narrative

(b)(4).

Event Description

Reportedly, at interrogation before implantation session the session was left open and the programmer showed the manager screen for unknown reason.The following interrogation before implantation showed shocks on but this has not been noticed.Device has been implanted in this status.Device has been shown a reset during follow-up after day of implantation and shock counter showed 4 shocks during implantation procedure (not observed by the physician).In addition, a warning message was displayed saying that last shock impedance was above 150 ohms after reset.Preliminary analysis showed that the reported behavior was most probably due to crosstalk between the icd and another device during interrogation of the device (before implantation).

• Brand Name: PLATINIUM
• Type of Device: DEFIBRILLATOR, IMPLANTABLE, DUAL-CHAMBER
• Manufacturer (Section D): SORIN GROUP ITALIA S.R.L. - CRM FACILITY; 4 avenue réaumur; parc d'affaires noveos; clamart, 92140 ; FR 92140
• Manufacturer (Section G): SORIN GROUP ITALIA SRL (SALUGGIA ITALY); 4 avenue réaumur; parc d'affaires noveos; clamart, 92140 ; FR 92140
• Manufacturer Contact: elodie vincent ; 4 avenue réaumur; parc d'affaires noveos; clamart, 92140 ; FR 92140 ; 0146013665
• MDR Report Key: 6572218
• MDR Text Key: 75343029
• Report Number: 1000165971-2017-00402
• Device Sequence Number: 1
• Product Code: MRM
• UDI-Device Identifier: 08031527014364
• UDI-Public: (01)08031527014364(11)160324(17)171024
• Combination Product (y/n): N
• Reporter Country Code: GM
• 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,Followup
• Report Date: 04/20/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/17/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 10/24/2017
• Device Model Number: PLATINIUM DR 1510
• Device Catalogue Number: PLATINIUM DR 1510
• Device Lot Number: S0163
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Distributor Facility Aware Date: 04/20/2017
• Event Location: Hospital
• Date Manufacturer Received: 09/21/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 03/24/2016
• 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
• Patient Outcome(s): Required Intervention