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

Device Problem Reset Problem (3019)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 03/22/2021

Event Type  malfunction  

Event 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 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.

Manufacturer Narrative

Please refer to the attached analysis report.

• Brand Name: PARADYM RF
• Type of Device: 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
• MDR Text Key: 253527419
• Report Number: 1000165971-2021-00474
• Device Sequence Number: 1
• Product Code: NIK
• UDI-Device Identifier: 08031527012278
• UDI-Public: (01)08031527012278(11)160309(17)170409
• Combination Product (y/n): N
• PMA/PMN Number: P060027
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative
• Type of Report: Initial,Followup
• Report Date: 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
• Device Operator: 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
• Initial Date Manufacturer Received: 05/07/2021
• Initial Date FDA Received: 06/01/2021
• Supplement Dates Manufacturer Received: 06/23/2021
• Supplement Dates FDA Received: 07/12/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1