MAUDE Adverse Event Report: SORIN GROUP ITALIA S.R.L. - CRM FACILITY PLATINIUM; DEFIBRILLATOR, AUTOMATIC IMPLANTABLE CARDIOVERTER,WITH CRT-D

Model Number	PLATINIUM CRT-D 1741
Medical Device Problem Codes	Premature Discharge of Battery (1057); High Capture Threshold (3266)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	12/19/2019
Type of Reportable Event	Serious Injury
Event or Problem Description
Reportedly, the subject crt-d and associated left ventricular lead were explanted on (b)(6) 2019.The re-intervention was performed due to a high left ventricular capture threshold.As the crt-d estimated residual longevity was less than a year, it was decided to replace it at the same time.
Additional Manufacturer Narrative
Analysis of the returned device did not reveal any anomaly.Based on available data, no issue is suspected on the battery.
Event or Problem Description
Reportedly, the subject crt-d and associated left ventricular lead were explanted on (b)(6) 2019.The re-intervention was performed due to a high left ventricular capture threshold.As the crt-d estimated residual longevity was less than a year, it was decided to replace it at the same time.
Additional Manufacturer Narrative
Please refer to the attached analysis report.- attachment: [20200417 - file-2020-00431 - analysis_and_closure_report_resp-2020-00419.Pdf].
Event or Problem Description
Reportedly, the subject crt-d and associated left ventricular lead were explanted on 19 december 2019.The re-intervention was performed due to a high left ventricular capture threshold.As the crt-d estimated residual longevity was less than a year, it was decided to replace it at the same time.

• Brand Name: PLATINIUM
• Common Device Name: DEFIBRILLATOR, AUTOMATIC IMPLANTABLE CARDIOVERTER,WITH CRT-D
• 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: 9793712
• Report Number: 1000165971-2020-00284
• Device Sequence Number: 16716473
• Product Code: NIK
• UDI-Device Identifier: 08031527015484
• UDI-Public: (01)08031527015484(11)160921(17)180421
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: P060027
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2017
• Device Explanted Year: 2019
• Reporter Type: Manufacturer
• Report Source: health professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 04/27/2020

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
• Operator of Device: Health Professional
• Device Expiration Date: 04/21/2018
• Device Model Number: PLATINIUM CRT-D 1741
• Device Catalogue Number: PLATINIUM CRT-D 1741
• Device Lot Number: S0218
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/18/2020
• Was the Report Sent to FDA?: No
• Distributor Facility Aware Date: 02/11/2020
• Initial Date Received by Manufacturer: 02/11/2020
• Supplement Date Received by Manufacturer: 03/23/2020; 04/17/2020
• Initial Report FDA Received Date: 03/05/2020
• Supplement Report FDA Received Date: 04/16/2020; 04/27/2020
• 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