MAUDE Adverse Event Report: SORIN GROUP ITALIA S.R.L. - CRM FACILITY PARADYM RF; DEFIBRILLATOR, IMPLANTABLE, DUAL-CHAMBER

Model Number	PARADYM RF DR 9550
Medical Device Problem Code	Premature Elective Replacement Indicator (1483)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/10/2021
Type of Reportable Event	Serious Injury
Event or Problem Description
Reportedly, the recommended replacement time (rrt) was reached earlier than expected.
Additional Manufacturer Narrative
Please refer to the attached analysis report.
Event or Problem Description
Reportedly, the recommended replacement time (rrt) was reached earlier than expected.

• Brand Name: PARADYM RF
• Common Device Name: DEFIBRILLATOR, IMPLANTABLE, DUAL-CHAMBER
• Manufacturer (Section D): SORIN GROUP ITALIA S.R.L. - CRM FACILITY; via crescentino s.n.; saluggia (vc), 13040 ; IT 13040
• Manufacturer (Section G): SORIN GROUP ITALIA SRL VIA CRESCENTINO; via crescentino s.n.; saluggia (vc), 13040 ; IT 13040
• Manufacturer Contact: elodie vincent ; via crescentino s.n.; saluggia (vc), 13040 ; IT 13040
• MDR Report Key: 11753704
• Report Number: 1000165971-2021-00416
• Device Sequence Number: 3527623
• Product Code: MRM
• UDI-Device Identifier: 08031527012254
• UDI-Public: (01)08031527012254(11)141106(17)151206
• 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: 2015
• Device Explanted Year: 2021
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 01/28/2022

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: 12/06/2015
• Device Model Number: PARADYM RF DR 9550
• Device Catalogue Number: PARADYM RF DR 9550
• Device Lot Number: 2863
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/26/2021
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 04/05/2021
• Supplement Date Received by Manufacturer: 01/06/2022
• Initial Report FDA Received Date: 04/30/2021
• Supplement Report FDA Received Date: 01/28/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 11/06/2014
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Unknown