MAUDE Adverse Event Report: SORIN GROUP ITALIA S.R.L. - CRM FACILITY PARADYM RF; DEFIBRILLATOR, AUTO. IMPLANTABLE CARDIOVERTER, WITH CARDIAC RESYNCHRO. (CRT-D)

Model Number PARADYM RF SONR CRT-D 9770

Device Problem Mechanical Problem (1384)

Patient Problem No Information (3190)

Event Date 12/02/2015

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, on (b)(6) 2015 during an intervention performed to replace the lv lead, after tightening the screw, the screwdriver tip broke.This screwdriver tip remained inside the lv lead connection of the subject defibrillator, implanted since (b)(6) 2014.Normal lead impedance and threshold has been observed since.

Manufacturer Narrative

Please refer to the attached intermediate report, with recommendations to remove the screwdriver tip.The device was successfully explanted on (b)(6) 2019.- attachment: [20190502 - file-2019-01158 - intermediate_analysis_report_resp-2019-00576.Pdf].

Event Description

Reportedly, on (b)(6) 2015 during an intervention performed to replace the lv lead, after tightening the screw, the screwdriver tip broke.This screwdriver tip remained inside the lv lead connection of the subject defibrillator, implanted since 04 december 2014.Normal lead impedance and threshold has been observed since.

Event Description

Reportedly, on (b)(6) 2015 during an intervention performed to replace the lv lead, after tightening the screw, the screwdriver tip broke.This screwdriver tip remained inside the lv lead connection of the subject defibrillator, implanted since (b)(6) 2014.Normal lead impedance and threshold has been observed since.

• Brand Name: PARADYM RF
• Type of Device: DEFIBRILLATOR, AUTO. IMPLANTABLE CARDIOVERTER, WITH CARDIAC RESYNCHRO. (CRT-D)
• 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: 8549354
• MDR Text Key: 145513025
• Report Number: 1000165971-2019-00245
• Device Sequence Number: 1
• Product Code: NIK
• 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
• Report Date: 07/19/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 06/22/2015
• Device Model Number: PARADYM RF SONR CRT-D 9770
• Device Catalogue Number: PARADYM RF SONR CRT-D 9770
• Device Lot Number: 2824
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/23/2019
• Was the Report Sent to FDA?: No
• Distributor Facility Aware Date: 04/02/2019
• Event Location: Hospital
• Initial Date Manufacturer Received: 04/02/2019
• Initial Date FDA Received: 04/25/2019
• Supplement Dates Manufacturer Received: 05/02/2019; 06/26/2019
• Supplement Dates FDA Received: 05/23/2019; 07/19/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1