MAUDE Adverse Event Report: SORIN GROUP ITALIA S.R.L. - CRM FACILITY PARADYM 2; DEFIBRILLATOR, IMPLANTABLE, DUAL-CHAMBER

Model Number PARADYM 2 DR 8552

Device Problem Reset Problem (3019)

Patient Problem No Information (3190)

Event Date 07/25/2018

Event Type  malfunction  

Manufacturer Narrative

The device involved in this mdr report is not approved in the united states; however, it is similar to a device manufactured by sorin that was cleared or approved by fda for marketing in the united states.

Event Description

Reportedly, patient implanted with the subject icd with atrial fibrillation was submitted to a cardioversion.During the procedure the device charges the capacitors and, after several attempted to delivery shock, the device delivered 2j and 1 efficient max shock.After the max shocks, the following alerts were displayed: [27] ¿ the device was reinitialised 2 times since the beginning of life.[a26] ¿ reset performed on (b)(6) 2018.[30] ¿ device programmed in nominal values after reset.[a1] ¿ low shock impedance on (b)(6) 2018.Defibrillation system potential inefficient.Preliminary analysis revealed that overload conditions were met on (b)(6) 2018 and confirmed that the 2 resets occurred and were due to a power on reset (i.E.An abrupt decrease of the battery voltage).

Event Description

Reportedly, patient implanted with the subject icd with atrial fibrillation was submitted to a cardioversion.During the procedure the device charges the capacitors and, after several attempted to delivery shock, the device delivered 2j and 1 efficient max shock.After the max shocks, the following alerts were displayed: the device was reinitialised 2 times since the beginning of life.Reset performed on (b)(6) 2018.Device programmed in nominal values after reset.Low shock impedance on (b)(6) 2018.Defibrillation system potential inefficient.Preliminary analysis revealed that overload conditions were met on (b)(6) 2018 and confirmed that the 2 resets occurred and were due to a power on reset (i.E.An abrupt decrease of the battery voltage).Updated on 31 aug 2018: the device has been explanted on (b)(6) 2018 and will be returned for analysis.

Manufacturer Narrative

Please refer to the attached analysis report.

Event Description

Reportedly, patient implanted with the subject icd with atrial fibrillation was submitted to a cardioversion.During the procedure the device charges the capacitors and, after several attempted to delivery shock, the device delivered 2j and 1 efficient max shock.After the max shocks, the following alerts were displayed: [27] ¿ the device was reinitialised 2 times since the beginning of life.[a26] ¿ reset performed on 25 july 2018.[30] ¿ device programmed in nominal values after reset.[a1] ¿ low shock impedance on 25 july 2018.Defibrillation system potential inefficient.Preliminary analysis revealed that overload conditions were met on 25 jul 2018 and confirmed that the 2 resets occurred and were due to a power on reset (i.E.An abrupt decrease of the battery voltage).Updated on 31 aug 2018: the device has been explanted on (b)(6) 2018 and will be returned for analysis.

Event Description

Reportedly, patient implanted with the subject icd with atrial fibrillation was submitted to a cardioversion.During the procedure the device charges the capacitors and, after several attempted to delivery shock, the device delivered 2j and 1 efficient max shock.After the max shocks, the following alerts were displayed: [27] ¿ the device was reinitialised 2 times since the beginning of life.[a26] ¿ reset performed on 25 july 2018.[30] ¿ device programmed in nominal values after reset.[a1] ¿ low shock impedance on 25 july 2018.Defibrillation system potential inefficient.Preliminary analysis revealed that overload conditions were met on 25 jul 2018 and confirmed that the 2 resets occurred and were due to a power on reset (i.E.An abrupt decrease of the battery voltage).Updated on 31 aug 2018: the device has been explanted on (b)(6) 2018 and will be returned for analysis.

Manufacturer Narrative

Preliminary analysis of returned capacitor did not reveal failure inside the capacitor.

Event Description

Reportedly, patient implanted with the subject icd with atrial fibrillation was submitted to a cardioversion.During the procedure the device charges the capacitors and, after several attempted to delivery shock, the device delivered 2j and 1 efficient max shock.After the max shocks, the following alerts were displayed: [27] ¿ the device was reinitialised 2 times since the beginning of life.[a26] ¿ reset performed on 25 july 2018.[30] ¿ device programmed in nominal values after reset.[a1] ¿ low shock impedance on 25 july 2018.Defibrillation system potential inefficient.Preliminary analysis revealed that overload conditions were met on 25 jul 2018 and confirmed that the 2 resets occurred and were due to a power on reset (i.E.An abrupt decrease of the battery voltage).Updated on 31 aug 2018: the device has been explanted on 31 aug 2018 and will be returned for analysis.

• Brand Name: PARADYM 2
• 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: 7762058
• MDR Text Key: 117009447
• Report Number: 1000165971-2018-00730
• Device Sequence Number: 1
• Product Code: MRM
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional
• Type of Report: Initial,Followup,Followup,Followup,Followup
• Report Date: 07/08/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/08/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 10/12/2015
• Device Model Number: PARADYM 2 DR 8552
• Device Catalogue Number: PARADYM 2 DR 8552
• Device Lot Number: 2849
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/13/2018
• Was the Report Sent to FDA?: No
• Distributor Facility Aware Date: 07/25/2018
• Date Manufacturer Received: 06/21/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1