MAUDE Adverse Event Report: Abbott Medical (CRM-Sylmar) ASSURITY MRI; Implantable Pulse Generator, Pacemaker (Non-Crt)

Model Number	PM2272
Medical Device Problem Code	No Apparent Adverse Event (3189)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	09/16/2026
Type of Reportable Event	Malfunction

• Brand Name: ASSURITY MRI
• Common Device Name: Implantable Pulse Generator, Pacemaker (Non-Crt)
• 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: 50952899
• Report Number: 2017865-2026-20771
• Device Sequence Number: 9624197
• Product Code: LWP
• UDI-Device Identifier: 05414734509589
• UDI-Public: (01)05414734509589(10)A000077914(17)201031
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: P140033
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2019
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Other
• Initial Reporter Occupation: Non-Healthcare Professional
• Remedial Action: Recall
• Type of Report: Initial
• Report Date (Section B): 09/30/2026

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: Other
• Device Expiration Date: 10/31/2020
• Device Model Number: PM2272
• Device Lot Number: A000077914
• Was Device Available for Evaluation?: Yes
• Date Returned to Manufacturer: 08/24/2026
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/16/2026
• Initial Report FDA Received Date: 09/30/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 04/09/2019
• 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
• If action reported to FDA under 21 USC 360i(g), list FDA-assigned Recall Number or include a statement: Z-1530-2021
• Patient Sequence Number: 1
• Patient Sex: Unknown