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	Failure to Capture (1081); Over-Sensing (1438)
Health Effect - Clinical Code	Dizziness (2194)
Date of Event	06/22/2021
Type of Reportable Event	Serious Injury
Event or Problem Description
Reportedly, the patient had dizziness for a couple of weeks.Upon interrogation of the crt-d, noise oversensing and loss of capture were observed on the right ventricular channel.Preliminary analysis revealed that a ventricular lead issue is suspected.
Additional Manufacturer Narrative
Preliminary analysis of the returned device confirmed that electrical and mechanical characteristics were within specifications.
Event or Problem Description
Reportedly, the patient had dizziness for a couple of weeks.Upon interrogation of the crt-d, noise oversensing and loss of capture were observed on the right ventricular channel.Preliminary analysis revealed that a ventricular lead issue is suspected.
Additional Manufacturer Narrative
Please refer to the attached analysis report.
Event or Problem Description
Reportedly, the patient had dizziness for a couple of weeks.Upon interrogation of the crt-d, noise oversensing and loss of capture were observed on the right ventricular channel.Preliminary analysis revealed that a ventricular lead issue is suspected.

• 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
• Manufacturer (Section G): SORIN GROUP ITALIA SRL VIA CRESCENTINO SALUGGIA; 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: 12163802
• Report Number: 1000165971-2021-00560
• Device Sequence Number: 11750280
• Product Code: NIK
• UDI-Device Identifier: 08031527012278
• UDI-Public: (01)08031527012278(11)150128(17)160228
• 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: 2021
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 01/11/2022

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: 02/28/2016
• Device Model Number: PARADYM RF CRT-D 9750
• Device Catalogue Number: PARADYM RF CRT-D 9750
• Device Lot Number: S0063
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/01/2021
• Is the Reporter a Health Professional?: Yes
• Initial Date Received by Manufacturer: 06/22/2021
• Supplement Date Received by Manufacturer: 09/08/2021; 12/24/2021
• Initial Report FDA Received Date: 07/13/2021
• Supplement Report FDA Received Date: 10/08/2021; 01/11/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 01/28/2015
• 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