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

Model Number	PLATINIUM VR 1210
Medical Device Problem Code	Insufficient Device Problem Information (3190)
Health Effect - Clinical Codes	No Information (3190); No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/13/2020
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
A complaint on this device was previously recorded and reported under mdr reference 1000165971-2017-00082.At this stage, it is unknown if the two events are linked.
Event or Problem Description
Reportedly, on (b)(6) 2020, the subject icd was replaced as it was malfunctioning.
Additional Manufacturer Narrative
Preliminary analysis revealed that high shock impedance was measured on (b)(6) 2019, before that the associated (non-microport crm) ventricular lead was replaced.It also revealed that during a follow-up on (b)(6) 2020, shocks induced during tests could not be delivered.Upon reception, the subject icd was not able to shock.An icd hardware issue and/or a ventricular lead issue are suspected.
Event or Problem Description
Reportedly, on (b)(6) 2020, the subject icd was replaced as it was malfunctioning.
Event or Problem Description
Reportedly, on (b)(6) 2020, the subject icd was replaced as it was malfunctioning.
Additional Manufacturer Narrative
Please refer to the attached analysis report.

• Brand Name: PLATINIUM
• Common Device Name: DEFIBRILLATOR, IMPLANTABLE, DUAL-CHAMBER
• Manufacturer (Section D): MICROPORT CRM S.R.L.; via crescentino s.n.; .; saluggia (vc), 13040 ; IT 13040
• MDR Report Key: 10993357
• Report Number: 1000165971-2020-00799
• Device Sequence Number: 3699168
• Product Code: MRM
• UDI-Device Identifier: 08031527015514
• UDI-Public: (01)08031527015514(11)160823(17)180323
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: P980049
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2017
• Device Explanted Year: 2020
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: health professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 04/01/2021

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
• Operator of Device: Health Professional
• Device Expiration Date: 03/23/2018
• Device Model Number: PLATINIUM VR 1210
• Device Catalogue Number: PLATINIUM VR 1210
• Device Lot Number: S0205
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/20/2021
• Was the Report Sent to FDA?: No
• Distributor Facility Aware Date: 11/18/2020
• Initial Date Received by Manufacturer: 11/18/2020
• Supplement Date Received by Manufacturer: 01/27/2021; 03/04/2021
• Initial Report FDA Received Date: 12/11/2020
• Supplement Report FDA Received Date: 02/19/2021; 04/01/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention