MAUDE Adverse Event Report: MICROPORT CRM S.R.L. PLATINIUM; DEFIBRILLATOR, AUTOMATIC IMPLANTABLE CARDIOVERTER, CARDIAC RESYNCHRONIZATION

Model Number PLATINIUM SONR CRT-D 1811

Device Problems Failure to Capture (1081); High impedance (1291)

Patient Problems No Information (3190); Insufficient Information (4580)

Event Date 01/02/2021

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 microport crm that was cleared or approved by fda for marketing in the united states.

Event Description

The crt-d was implanted on (b)(6) 2020 and connected to the associated left ventricular lead, which was implanted on (b)(6) 2013.The patient is pacing-dependent.Reportedly, during a remote follow-up performed on (b)(6) 2021, it was observed that left ventricular lead impedance measurements abruptly increased and were saturated at 3000 ohms.A follow-up was then performed on (b)(6) 2021, left ventricular lead impedance measurement saturated at 3000 ohms was observed.In addition, loss of ventricular capture in lv ring ¿ rv coil configuration was noticed.The left ventricular pacing configuration was reprogrammed to lv tip ¿ rv coil.The ventricular capture threshold was elevated but proper capture was confirmed.Left ventricular lead impedance measurement was within normal range.It was decided to keep this configuration programmed and to follow closely the patient via remote monitoring in case of re-occurrence of lead issues.Preliminary analysis revealed that abnormal left ventricular lead impedance measurements most probably resulted from a left ventricular lead issue.

Manufacturer Narrative

Please refer to the attached analysis report.

Event Description

The crt-d was implanted on (b)(6) 2020 and connected to the associated left ventricular lead, which was implanted on (b)(6) 2013.The patient is pacing-dependent.Reportedly, during a remote follow-up performed on (b)(6) 2021, it was observed that left ventricular lead impedance measurements abruptly increased and were saturated at 3000 ohms.A follow-up was then performed on (b)(6) 2021, left ventricular lead impedance measurement saturated at 3000 ohms was observed.In addition, loss of ventricular capture in lv ring - rv coil configuration was noticed.The left ventricular pacing configuration was reprogrammed to lv tip - rv coil.The ventricular capture threshold was elevated but proper capture was confirmed.Left ventricular lead impedance measurement was within normal range.It was decided to keep this configuration programmed and to follow closely the patient via remote monitoring in case of re-occurrence of lead issues.Preliminary analysis revealed that abnormal left ventricular lead impedance measurements most probably resulted from a left ventricular lead issue.

Event Description

The crt-d was implanted on (b)(6) 2020 and connected to the associated left ventricular lead, which was implanted on (b)(6) 2013.The patient is pacing-dependent.Reportedly, during a remote follow-up performed on (b)(6) 2021, it was observed that left ventricular lead impedance measurements abruptly increased and were saturated at 3000 ohms.A follow-up was then performed on (b)(6) 2021, left ventricular lead impedance measurement saturated at 3000 ohms was observed.In addition, loss of ventricular capture in lv ring - rv coil configuration was noticed.The left ventricular pacing configuration was reprogrammed to lv tip - rv coil.The ventricular capture threshold was elevated but proper capture was confirmed.Left ventricular lead impedance measurement was within normal range.It was decided to keep this configuration programmed and to follow closely the patient via remote monitoring in case of re-occurrence of lead issues.Preliminary analysis revealed that abnormal left ventricular lead impedance measurements most probably resulted from a left ventricular lead issue.

Manufacturer Narrative

D3 - g1 corrected.Microport crm was notified on (b)(6) 2021 that a re-intervention was performed on the same day to replace the associated left ventricular lead, since its impedance value was higher than 4000 ohms.The left ventricular lead was abandoned in patient's body.

• Brand Name: PLATINIUM
• Type of Device: DEFIBRILLATOR, AUTOMATIC IMPLANTABLE CARDIOVERTER, CARDIAC RESYNCHRONIZATION
• Manufacturer (Section D): MICROPORT CRM S.R.L.; via crescentino s.n.; .; saluggia (vc), 13040 ; IT 13040
• MDR Report Key: 11273904
• MDR Text Key: 233742413
• Report Number: 1000165971-2021-00257
• Device Sequence Number: 1
• Product Code: NIK
• UDI-Device Identifier: 08031527014388
• UDI-Public: (01)08031527014388(11)181205(17)200705
• 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: 08/30/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/03/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 07/05/2020
• Device Model Number: PLATINIUM SONR CRT-D 1811
• Device Catalogue Number: PLATINIUM SONR CRT-D 1811
• Device Lot Number: S0347
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Distributor Facility Aware Date: 01/08/2021
• Date Manufacturer Received: 08/06/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1