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 Code	Reset Problem (3019)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/22/2021
Type of Reportable Event	Malfunction
Event or Problem Description
Reportedly, upon device interrogation on (b)(6) 2021, a warning stating that a reset occurred on (b)(6) 2021 and re-initialization was performed was displayed.The last battery reforming was performed on (b)(6) 2021.On (b)(6) 2021, the battery voltage was at 2.88v.A charge time of 15s was measured.The device was successfully reprogrammed and the statistics were reset.Proper device operation was observed.The patient had undergone several surgeries since the beginning of the year.
Event or Problem Description
Reportedly, upon device interrogation on (b)(6) 2021, a warning stating that a reset occurred on (b)(6) 2021 and re-initialization was performed was displayed.The last battery reforming was performed on (b)(6) 2021.On (b)(6) 2021, the battery voltage was at 2.88v.A charge time of 15s was measured.The device was successfully reprogrammed and the statistics were reset.Proper device operation was observed.The patient had undergone several surgeries since the beginning of the year.
Additional Manufacturer Narrative
Please refer to the attached analysis report.

• 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: 11913198
• Report Number: 1000165971-2021-00474
• Device Sequence Number: 11812128
• Product Code: NIK
• UDI-Device Identifier: 08031527012278
• UDI-Public: (01)08031527012278(11)160309(17)170409
• 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
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 07/12/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 04/09/2017
• Device Model Number: PARADYM RF CRT-D 9750
• Device Catalogue Number: PARADYM RF CRT-D 9750
• Device Lot Number: S0158
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/07/2021
• Supplement Date Received by Manufacturer: 06/23/2021
• Initial Report FDA Received Date: 06/01/2021
• Supplement Report FDA Received Date: 07/12/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1