MAUDE Adverse Event Report: ABBOTT CURRENT PLUS VR, DF-4 CONNECTOR; PULSE GENERATOR, PERMANENT, IMPLANTABLE

Model Number	CD1211-36Q
Medical Device Problem Code	Premature Discharge of Battery (1057)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/21/2025
Type of Reportable Event	Serious Injury
Event or Problem Description
During an in-clinic follow-up, the device was found to be at elective replacement indicator (eri) sooner than expected.Premature battery depletion is suspected, although not confirmed.A device replacement is anticipated.The patient is stable and will continue to be monitored.
Event or Problem Description
Additional report is needed to include the verbiage that an additional surgery occurred, and the device was explanted and replaced to resolve the event.
Additional Manufacturer Narrative
The reported event of longevity anomalies and premature discharge of battery were not confirmed.The device was received with normal output and telemetry communication.Analysis of the device image indicated the device was operating at elective-replacement level and was implanted beyond its projected longevity.At this stage, the battery¿s capacity is significantly reduced, and its voltage level is sensitive to variations such as auto settings responsive, capacitors maintenance, and prolong telemetry interrogation.These conditions can result in fluctuation of battery voltage level measurements, which affects the longevity estimates.Device was implanted for 9.46 years which exceeded its projected longevity and is consistent with normal battery depletion.Electrical and mechanical tests performed including telemetry communication and output verification did not identify any functional issues.

• Brand Name: CURRENT PLUS VR, DF-4 CONNECTOR
• 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: 22893733
• Report Number: 2017865-2025-98500
• Device Sequence Number: 18366916
• Product Code: NVZ
• UDI-Device Identifier: 05414734503716
• UDI-Public: (01)05414734503716(10)S000012579(17)170430
• Combination Product (Y/N): N
• Initial Reporter Country: GM
• PMA/510(K) Number: P910023
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2016
• Device Explanted Year: 2025
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 12/11/2025

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: 04/30/2017
• Device Model Number: CD1211-36Q
• Device Lot Number: S000012579
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• 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: 08/21/2025
• Supplement Date Received by Manufacturer: 11/13/2025; 12/01/2025
• Initial Report FDA Received Date: 08/26/2025
• Supplement Report FDA Received Date: 11/13/2025; 12/11/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 10/20/2015
• 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
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Unknown