MAUDE Adverse Event Report: ABBOTT MEDICAL (CRM-SYLMAR) ACCENT DR RF PACEMAKER; Pulse generator, permanent, implantable

Model Number	PM2210
Medical Device Problem Code	Insufficient Device Problem Information (3190)
Health Effect - Clinical Code	Discomfort (2330)
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Further information was requested but not received.The product was returned.The interrogation results indicate eri, the visual screen was acceptable, and the longevity assessment was acceptable.
Event or Problem Description
It was reported that the patient experience chest pain.It was noted that the pacemaker was explanted and replaced.The patient condition was not known.

• Brand Name: ACCENT DR RF PACEMAKER
• Common Device Name: Pulse generator, permanent, implantable
• Manufacturer (Section D): ABBOTT MEDICAL (CRM-SYLMAR); 15900 valley view court; sylmar CA 91342
• Manufacturer (Section G): ABBOTT MEDICAL (CRM-SYLMAR); 15900 valley view court; sylmar CA 91342
• Manufacturer Contact: navpreet singh ; 15900 valley view court; sylmar, CA 91342
• MDR Report Key: 25673792
• Report Number: 2017865-2026-13925
• Device Sequence Number: 10407296
• Product Code: NVZ
• UDI-Device Identifier: 05414734503617
• UDI-Public: (01)05414734503617(10)4520524(17)150930
• Combination Product (Y/N): N
• Initial Reporter State: PA
• Initial Reporter Country: US
• PMA/510(K) Number: P880086
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2014
• Device Explanted Year: 2025
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional,User Facility,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 07/01/2026

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?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 09/30/2015
• Device Model Number: PM2210
• Device Lot Number: 4520524
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/11/2026
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/11/2026
• Initial Report FDA Received Date: 06/30/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 03/17/2014
• 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
• Concomitant Medical Products and Therapy/Usage Dates: TENDRIL SDX LEAD; TENDRIL SDX LEAD
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 84 YR
• Patient Sex: Male
• Patient Ethnicity: Non Hispanic
• Patient Race: White