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

Model Number PARADYM RF DR 9550

Device Problems Device Displays Incorrect Message (2591); Reset Problem (3019)

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

Event Date 03/14/2017

Event Type  Injury  

Event Description

The device was implanted on (b)(6) 2017.When the device was interrogated at hematoma evacuation, the following warning messages were displayed to the user : the device was reinitialized 1time since the beginning of life reset occurred on (b)(6) 2017 technical issue.Defibrillation system potentially ineffective.Contact sorin clarification required on causes of these warning messages.

Manufacturer Narrative

Preliminary analysis showed that the most probable cause of reset is an external perturbation during implant (could be esd or electromagnetic interferences or other).Note that the reported warning message[44] cannot be reset.

Event Description

The device was implanted on (b)(6) 2017.When the device was interrogated at hematoma evacuation, the following warning messages were displayed to the user : [27]the device was reinitialized 1 time since the beginning of life.[59] reset occurred on (b)(6) 2017.[44] technical issue.Defibrillation system potentially ineffective.Contact sorin.Clarification required on causes of these warning messages.

Manufacturer Narrative

Please refer to the attached analysis report.

Event Description

The device was implanted on (b)(6) 2017.When the device was interrogated at hematoma evacuation, the following warning messages were displayed to the user : [27] the device was reinitialized 1time since the beginning of life.[59] reset occurred on (b)(6) 2017.[44] technical issue.Defibrillation system potentially ineffective.Contact sorin.Clarification required on causes of these warning messages.

• Brand Name: PARADYM RF
• Type of Device: DEFIBRILLATOR, IMPLANTABLE, DUAL-CHAMBER
• Manufacturer (Section D): SORIN GROUP ITALIA S.R.L. - CRM FACILITY; parc d'affaires noveos; 4 avenue reaumur; clamart, 92140 ; FR 92140
• Manufacturer (Section G): SORIN GROUP ITALIA SRL VIA CRESCENTINO 13040; parc d'affaires noveos; 4 avenue reaumur; clamart, 92140 ; FR 92140
• Manufacturer Contact: elodie vincent ; parc d'affaires noveos; 4 avenue reaumur; clamart, 92140 ; FR 92140 ; 0146013665
• MDR Report Key: 6490078
• MDR Text Key: 72735718
• Report Number: 1000165971-2017-00316
• Device Sequence Number: 1
• Product Code: MRM
• Combination Product (y/n): N
• Reporter Country Code: AS
• PMA/PMN Number: P060027
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,other
• Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup
• Report Date: 03/17/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/13/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 10/09/2017
• Device Model Number: PARADYM RF DR 9550
• Device Catalogue Number: PARADYM RF DR 9550
• Device Lot Number: S0211
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Distributor Facility Aware Date: 03/17/2017
• Event Location: Hospital
• Date Manufacturer Received: 10/24/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 09/09/2016
• 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