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

Model Number	PM2240
Medical Device Problem Code	No Apparent Adverse Event (3189)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	08/14/2026
Type of Reportable Event	Malfunction
Event or Problem Description
The product was returned without a complaint associated to the product and there is no allegation of a malfunction for this product.
Additional Manufacturer Narrative
No complaint was received with the return of the device.Failure event observed during analysis.The device was received with normal telemetry and output.Visual inspection of the header attachment area detected an anomaly between the epoxy header and titanium case.A device history record (dhr) review was performed and all required manufacturing processes and inspections steps were confirmed to be completed per the requirements.The device met specifications prior to leaving abbott manufacturing facilities.Longevity assessment found the device was operating at the elective replacement indicator (eri) voltage consistent with normal usage.A manufacturing process anomaly consistent with header bonding anomaly may have occurred.The device is included in the assurity and endurity pacemakers header anomaly advisory issued by abbott on 15 march 2021.

• Brand Name: Assurity RF DR
• 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: 50594816
• Report Number: 2017865-2026-18659
• Device Sequence Number: 10225305
• Product Code: NVZ
• UDI-Device Identifier: 05414734507073
• UDI-Public: (01)05414734507073(10)A000018213(17)170831
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: P880086
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2016
• 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): 09/03/2026

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: 08/31/2017
• Device Model Number: PM2240
• Device Lot Number: A000018213
• Was Device Available for Evaluation?: Yes
• Date Returned to Manufacturer: 06/23/2026
• 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: Not provided
• Initial Report FDA Received Date: 09/03/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 02/16/2016
• 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