MAUDE Adverse Event Report: MICROPORT CRM S.R.L. PLATINIUM; DEFIBRILLATOR, IMPLANTABLE, DUAL-CHAMBER

Model Number PLATINIUM VR 1240

Device Problems Over-Sensing (1438); Low impedance (2285)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 07/27/2020

Event Type  Injury  

Event Description

Reportedly, during the follow-up on (b)(6) 2020, an alert was observed stating that the ventricular lead impedance was below 200 ohms on (b)(6) 2020.The lead impedance curve showed intermittent drops from 500 ohms to 200 ohms, starting from around (b)(6) 2020.During the follow-up, all impedance values were measured within normal range and the charge time test was 15 seconds, which seems high for an icd that has been implanted for 4 years.On (b)(6) 2020, an alert was received on the remote monitoring report stating that the ventricular lead impedance was below 200 ohms on (b)(6) 2020, with this criterion reached for 3 consecutive days.The lead and coil impedance curves showed intermittent drops below normal range.On (b)(6) 2020, the icd was interrogated showing normal lead and coil impedance values and a high pacing threshold that has been constant for several years.A charge time test was manually performed at 14 seconds.The episodes recorded in the device memory showed oversensing for several years, which could be due to myopotentials.During both the follow-ups, traction tests and valsalva maneuvers were performed, however no event was reproduced.Preliminary analysis revealed that the beginning of a ventricular lead issue is suspected.

Manufacturer Narrative

Please refer to the attached analysis report.

Event Description

Reportedly, during the follow-up on (b)(6) 2020 an alert was observed stating that the ventricular lead impedance was below 200 ohms on (b)(6) 2020.The lead impedance curve showed intermittent drops from 500 ohms to 200 ohms, starting from around (b)(6) 2020.During the follow-up, all impedance values were measured within normal range and the charge time test was 15 seconds, which seems high for an icd that has been implanted for 4 years.On (b)(6) 2020, an alert was received on the remote monitoring report stating that the ventricular lead impedance was below 200 ohms on (b)(6) 2020, with this criterion reached for 3 consecutive days.The lead and coil impedance curves showed intermittent drops below normal range.On (b)(6) 2020, the icd was interrogated showing normal lead and coil impedance values and a high pacing threshold that has been constant for several years.A charge time test was manually performed at 14 seconds.The episodes recorded in the device memory showed oversensing for several years, which could be due to myopotentials.During both the follow-ups, traction tests and valsalva maneuvers were performed, however no event was reproduced.Preliminary analysis revealed that the beginning of a ventricular lead issue is suspected.

• Brand Name: PLATINIUM
• Type of Device: DEFIBRILLATOR, IMPLANTABLE, DUAL-CHAMBER
• Manufacturer (Section D): MICROPORT CRM S.R.L.; via crescentino s.n.; .; saluggia (vc) 13040 ; IT 13040
• MDR Report Key: 10499521
• MDR Text Key: 205886284
• Report Number: 1000165971-2020-00594
• Device Sequence Number: 1
• Product Code: MRM
• UDI-Device Identifier: 08031527014395
• UDI-Public: (01)08031527014395(11)151019(17)170519
• Combination Product (y/n): N
• PMA/PMN Number: P980049
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional
• Type of Report: Initial,Followup
• Report Date: 11/17/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 05/19/2017
• Device Model Number: PLATINIUM VR 1240
• Device Catalogue Number: PLATINIUM VR 1240
• Device Lot Number: S0120
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Distributor Facility Aware Date: 08/13/2020
• Initial Date Manufacturer Received: 08/13/2020
• Initial Date FDA Received: 09/07/2020
• Supplement Dates Manufacturer Received: 10/27/2020
• Supplement Dates FDA Received: 11/17/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention