MAUDE Adverse Event Report: SORIN GROUP ITALIA S.R.L. - CRM FACILITY PARADYM RF; DEFIBRILLATOR, AUTO. IMPLANTABLE CARDIOVERTER, WITH CARDIAC RESYNCHRO. (CRT-D)

Model Number	PARADYM RF CRT-D 9750
Medical Device Problem Codes	Premature Discharge of Battery (1057); Premature Elective Replacement Indicator (1483)
Health Effect - Clinical Codes	No Known Impact Or Consequence To Patient (2692); No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/23/2020
Type of Reportable Event	Serious Injury
Event or Problem Description
Reportedly, the subject device reached the recommended replacement time (rrt) early.
Event or Problem Description
Reportedly, the subject device reached the recommended replacement time (rrt) early.

• Brand Name: PARADYM RF
• Common Device Name: DEFIBRILLATOR, AUTO. IMPLANTABLE CARDIOVERTER, WITH CARDIAC RESYNCHRO. (CRT-D)
• Manufacturer (Section D): SORIN GROUP ITALIA S.R.L. - CRM FACILITY; via crescentino s.n.; .; saluggia (vc), 13040 ; IT 13040
• MDR Report Key: 11100333
• Report Number: 1000165971-2020-00863
• Device Sequence Number: 17089081
• Product Code: NIK
• UDI-Device Identifier: 08031527012278
• UDI-Public: (01)08031527012278(11)151016(17)161116
• 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: 2016
• Device Explanted Year: 2020
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: company representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 05/12/2021

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: 11/16/2016
• Device Model Number: PARADYM RF CRT-D 9750
• Device Catalogue Number: PARADYM RF CRT-D 9750
• Device Lot Number: S0121
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/06/2021
• Was the Report Sent to FDA?: No
• Distributor Facility Aware Date: 12/08/2020
• Event Location: Hospital
• Initial Date Received by Manufacturer: 12/08/2020
• Supplement Date Received by Manufacturer: 04/16/2021
• Initial Report FDA Received Date: 12/31/2020
• Supplement Report FDA Received Date: 05/12/2021
• 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