MAUDE Adverse Event Report: ABBOTT ENDURITY DR; PULSE GENERATOR, PERMANENT, IMPLANTABLE

Model Number	PM2160
Medical Device Problem Code	Incorrect Measurement (1383)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/15/2026
Type of Reportable Event	Malfunction
Event or Problem Description
During an in clinic follow up in (b)(6) 2025 the device showed 6 months of battery remaining.Another in clinic follow up was performed on (b)(6) 2026 and showed 11.8 months of battery remaining.Technical support was contacted and a diagnostic anomaly was suspected as the 11.8 month remaining battery estimation was deemed correct.Further investigation was recommended by technical support.No intervention has been performed.The patient was stable and will continue being monitored.

• Brand Name: ENDURITY DR
• Common Device Name: PULSE GENERATOR, PERMANENT, IMPLANTABLE
• Manufacturer (Section D): ABBOTT; 15900 valley view court; sylmar CA 91342
• Manufacturer (Section G): ABBOTT; 15900 valley view court; sylmar CA 91342
• Manufacturer Contact: navpreet singh ; 15900 valley view court; sylmar, CA 91342
• MDR Report Key: 24254089
• Report Number: 2017865-2026-02340
• Device Sequence Number: 20919261
• Product Code: NVZ
• UDI-Device Identifier: 05414734507059
• UDI-Public: (01)05414734507059(10)4859887(17)160430
• Combination Product (Y/N): N
• Initial Reporter Country: UK
• PMA/510(K) Number: P880086
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2014
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 03/16/2026

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: Health Professional
• Device Expiration Date: 04/30/2016
• Device Model Number: PM2160
• Device Lot Number: 4859887
• 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: 01/15/2026
• Supplement Date Received by Manufacturer: 03/16/2026
• Initial Report FDA Received Date: 02/03/2026
• Supplement Report FDA Received Date: 03/16/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 10/31/2014
• 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
• Patient Sex: Unknown