MAUDE Adverse Event Report: Abbott Medical (CRM-Sylmar) Accent DR RF pacemaker; Pulse Generator, Permanent, Implantable

Model Number	PM2210
Medical Device Problem Code	Low impedance (2285)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that the patient presented to the clinic for follow-up.Low pacing impedance measurements were observed while the pacemaker (pm) was at the normal elective replacement indicator (eri) stage.Consequently, the pm was explanted and replaced with a new pm on (b)(6)2026.The existing atrial and right ventricle (rv) leads were retained and successfully reconnected to the newly implanted pm.Subsequent pacing system analyzer (psa) testing and lead impedance measurements performed after reconnection to the replacement pm were within normal limits, indicating acceptable lead impedance measurements with both the explanted and replacement pms.The patient was stable throughout.

• 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: 50706609
• Report Number: 2017865-2026-18898
• Device Sequence Number: 21493903
• Product Code: NVZ
• UDI-Device Identifier: 05414734503617
• UDI-Public: (01)05414734503617(10)4379705(17)150630
• Combination Product (Y/N): N
• Initial Reporter State: TX
• 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: 2026
• 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): 09/10/2026

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: 06/30/2015
• Device Model Number: PM2210
• Device Lot Number: 4379705
• Was Device Available for Evaluation?: No
• 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: 08/27/2026
• Initial Report FDA Received Date: 09/10/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 12/08/2013
• 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: 1788TC/46 lead; 1788TC/52 lead
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 78 YR
• Patient Sex: Female