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 Problem Unable to Obtain Readings (1516)

Patient Problem Shock (2072)

Event Date 02/19/2016

Event Type  malfunction  

Event Description

Reportedly, due to an electrical storm on (b)(6) 2016, the icd delivered numerous shocks.When the physician interrogated the device on (b)(6) 2016, no arrhythmia episode was found in device memories.An explanation is requested.

Manufacturer Narrative

Preliminary analysis showed that the device memories were reset by the user before the end of aida (device memories) reading.Consequently, no arrhythmia episode was found in device memories.This behavior is in accordance with the specifications.

Event Description

Reportedly, due to an electrical storm on (b)(6) 2016, the icd delivered numerous shocks.When the physician interrogated the device on (b)(6) 2016, no arrhythmia episode was found in device memories.An explanation is requested.

Manufacturer Narrative

Preliminary analysis of the arrhythmia episodes stored in device memories showed noise oversensing in both channels (noise was mostly detected in the atrial channel) and also ventricular capture failure was noted in some of the stored episodes.The observed noise pattern suggests that the noise would probably originate from emi and/or myopotentials but the lead(s) issue cannot be excluded at this level.Analysis is ongoing.

Event Description

Reportedly, due to an electrical storm on (b)(6) 2016, the icd delivered numerous shocks.When the physician interrogated the device on (b)(6) 2016, no arrhythmia episode was found in device memories.An explanation is requested.

Manufacturer Narrative

Please refer to the attached analysis report for complete details.

Event Description

Reportedly, due to an electrical storm on (b)(6) 2016, the icd delivered numerous shocks.When the physician interrogated the device on (b)(6) 2016, no arrhythmia episode was found in device memories.An explanation is requested.

Manufacturer Narrative

It was reported that the device was explanted (the date is unknown) and will be returned for analysis.

Event Description

Reportedly, due to an electrical storm on (b)(6) 2016, the icd delivered numerous shocks.When the physician interrogated the device on (b)(6) 2016, no arrhythmia episode was found in device memories.An explanation is requested.

Manufacturer Narrative

The information provided in previous medwatch (medwatch submission # mdr-2017-00627) was confirmed to be erroneous.The subject device never arrived for analysis.It is unknown whether the device was explanted.

Event Description

Reportedly, due to an electrical storm on (b)(6) 2016, the icd delivered numerous shocks.When the physician interrogated the device on (b)(6) 2016, no arrhythmia episode was found in device memories.An explanation is requested.

• 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 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: elodie vincent ; parc d'affaires noveos 4 avenue réaumur; .; clamart 92140 ; FR 92140 ; 0146013665
• MDR Report Key: 5476615
• MDR Text Key: 39846579
• Report Number: 1000165971-2016-00144
• Device Sequence Number: 1
• Product Code: MRM
• Combination Product (y/n): N
• Reporter Country Code: FR
• PMA/PMN Number: P060027
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup,Followup,Followup
• Report Date: 02/19/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/03/2016
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 01/03/2015
• Device Model Number: PARADYM RF DR 9550
• Device Catalogue Number: PARADYM RF DR 9550
• Device Lot Number: 2786
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Distributor Facility Aware Date: 02/19/2016
• Event Location: Hospital
• Date Manufacturer Received: 06/19/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 12/03/2013
• 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