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 Nonstandard Device (1420); Unable to Obtain Readings (1516); Loss of Data (2903)

Patient Problems Dizziness (2194); Palpitations (2467)

Event Date 06/29/2018

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, on (b)(6) 2018, the patient was sent to emergency unit because of palpitations.The same day, the subject pacemaker was interrogated and the following message was displayed in aida (device memory) upon several interrogations: no sustained arrhythmias detected.No egm was recorded in device memory.Reportedly, it took time to load data and to reprogram ventricular parameters (deactivation of the auto-threshold function, pacing amplitude set to a fixed value and change of the pacing polarity, since it was considered that it could be the cause of the palpitations).The 24 hours heart rate curve showed cardiac rate that did not go above 110 bpm: the rhythm did not appear to be so fast as to provoke the palpitations and the symptoms of dizziness and daze felt by the patient.

Manufacturer Narrative

Please refer to the attached analysis report.

Event Description

Reportedly, on (b)(6) 2018, the patient was sent to emergency unit because of palpitations.The same day, the subject pacemaker was interrogated and the following message was displayed in aida (device memory) upon several interrogations: no sustained arrhythmias detected.No egm was recorded in device memory.Reportedly, it took time to load data and to reprogram ventricular parameters (deactivation of the auto-threshold function, pacing amplitude set to a fixed value and change of the pacing polarity, since it was considered that it could be the cause of the palpitations).The 24 hours heart rate curve showed cardiac rate that did not go above 110 bpm: the rhythm did not appear to be so fast as to provoke the palpitations and the symptoms of dizziness and daze felt by the patient.

• 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: 7707072
• MDR Text Key: 114807106
• Report Number: 1000165971-2018-00675
• Device Sequence Number: 0
• Product Code: LWP
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional
• Remedial Action: Recall
• Type of Report: Initial,Followup
• Report Date: 10/02/2018
• 2 Devices were Involved in the Event: 1 2

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: 01/21/2018
• Device Model Number: KORA 100 DR
• Device Catalogue Number: KORA 100 DR
• Device Lot Number: S0193
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Distributor Facility Aware Date: 06/29/2018
• Event Location: Hospital
• Initial Date Manufacturer Received: 06/29/2018
• Initial Date FDA Received: 07/20/2018
• Supplement Dates Manufacturer Received: 09/19/2018
• Supplement Dates FDA Received: 10/02/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Removal/Correction Number: Z-0413-2017
• Patient Sequence Number: 1