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

Model Number PLATINIUM VR 1210

Device Problem Low impedance (2285)

Patient Problem No Information (3190)

Event Date 01/20/2021

Event Type  Injury  

Event Description

Reportedly, during a follow-up, low lead impedance and rv coil continuity measurements, below 200 ohms, were observed.Since the previous follow-up, several ventricular arrhythmias were recorded and treated with atp and shock therapies.Due to the low lead impedance measurements, the estimated residual longevity could not be displayed.

• 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
• Manufacturer (Section G): MICROPORT CRM S.R.L.; via crescentino s.n.; .; saluggia (vc) 13040 ; IT 13040
• Manufacturer Contact: laura ouaki ; via crescentino s.n.; .; saluggia (vc) 13040 ; IT 13040 ; 146013429
• MDR Report Key: 11326091
• MDR Text Key: 233739719
• Report Number: 1000165971-2021-00289
• Device Sequence Number: 1
• Product Code: MRM
• UDI-Device Identifier: 08031527014357
• UDI-Public: (01)08031527014357(11)150618(17)161218
• Combination Product (y/n): N
• Reporter Country Code: PO
• PMA/PMN Number: P980049
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 02/14/2021

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: 12/18/2016
• Device Model Number: PLATINIUM VR 1210
• Device Catalogue Number: PLATINIUM VR 1210
• Device Lot Number: S0088
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Distributor Facility Aware Date: 01/20/2021
• Event Location: Hospital
• Initial Date Manufacturer Received: 01/20/2021
• Initial Date FDA Received: 02/14/2021
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 06/18/2015
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention