MAUDE Adverse Event Report: SORIN GROUP ITALIA S.R.L. - CRM FACILITY KORA; IMPLANTABLE PULSE GENERATOR, PACEMAKER (NON-CRT)

Model Number KORA 100 DR

Device Problems Premature Discharge of Battery (1057); Failure to Capture (1081); Failure to Sense (1559)

Patient Problem No Information (3190)

Event Date 06/30/2020

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

The pacing system was implanted on (b)(6) 2014.Reportedly, a re-intervention was performed because of battery depletion of the subject pacemaker.The battery impedance was 2.89 kohms with a minimal estimating residual longevity of 8 months.The electrical performances of the ventricular lead were within normal range but absence of sensing and capture was observed for the atrial lead.On x-rays, no issue was observed regarding the atrial lead positioning.Absence of capture and sensing was confirmed with a psa and it was decided to replace the atrial lead.As the lead could not be extracted, it was decided to cap and abandon it.It was difficult to implant the new atrial lead due to the abandoned lead.After several attempts, a site with stable but low detection was found and it was decided to fix the lead there.Preliminary analysis revealed that normal battery depletion occurred according to hrs guidelines.The electrical characteristics of the returned pacemaker were within specifications.The reported electrical irregularities on the atrial channel could have resulted from an atrial lead tip displacement and/or an atrial lead issue.

Event Description

The pacing system was implanted on 18 december 2014.Reportedly, a re-intervention was performed because of battery depletion of the subject pacemaker.The battery impedance was 2.89 kohms with a minimal estimating residual longevity of 8 months.The electrical performances of the ventricular lead were within normal range but absence of sensing and capture was observed for the atrial lead.On x-rays, no issue was observed regarding the atrial lead positioning.Absence of capture and sensing was confirmed with a psa and it was decided to replace the atrial lead.As the lead could not be extracted, it was decided to cap and abandon it.It was difficult to implant the new atrial lead due to the abandoned lead.After several attempts, a site with stable but low detection was found and it was decided to fix the lead there.Preliminary analysis revealed that normal battery depletion occurred according to hrs guidelines.The electrical characteristics of the returned pacemaker were within specifications.The reported electrical irregularities on the atrial channel could have resulted from an atrial lead tip displacement and/or an atrial lead issue.

• Brand Name: KORA
• Type of Device: IMPLANTABLE PULSE GENERATOR, PACEMAKER (NON-CRT)
• 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: 10319770
• MDR Text Key: 201406719
• Report Number: 1000165971-2020-00523
• Device Sequence Number: 1
• Product Code: LWP
• 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
• Report Date: 10/26/2020

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: 04/01/2016
• Device Model Number: KORA 100 DR
• Device Catalogue Number: KORA 100 DR
• Device Lot Number: S0037
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/15/2020
• Was the Report Sent to FDA?: No
• Distributor Facility Aware Date: 06/30/2020
• Initial Date Manufacturer Received: 06/30/2020
• Initial Date FDA Received: 07/24/2020
• Supplement Dates Manufacturer Received: 10/05/2020
• Supplement Dates FDA Received: 10/26/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1