MAUDE Adverse Event Report: ABBOTT MEDICAL (CRM-SYLMAR) ULTIPACE¿ LEAD, 58CM MRI; NO MATCH

Model Number	LPA1231/58
Medical Device Problem Codes	Failure to Capture (1081); Device Sensing Problem (2917); Device Dislodged or Dislocated (2923)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/11/2026
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that the patient presented in clinic for device check.Upon interrogation, capture failure was observed the right ventricular lead.R-wave amplitude variation was also observed.It was alleged that the right ventricular lead dislodged into the right atrium.The device was programmed to aai in order to mitigate the issue.Subsequently, the right ventricle lead was explanted and replaced on (b)(6) 2026.The patient was stable throughout.
Additional Manufacturer Narrative
The reported events were failure to capture, r-wave amplitude variation and lead dislodgement.As received, a complete lead was returned in one piece.The reported events of failure to capture and r-wave amplitude variation were not confirmed.Visual and x-ray examinations of the lead did not find any anomalies.Electrical testing of the lead did not find any indication of conductor fractures or internal shorts.Visual examination of the lead found the helix was retracted and clogged with blood/tissue.After cleaning and applying torque directly to the connector pin, the helix was able to extend and retract.The measured helix extension length was within specification.

• Brand Name: ULTIPACE¿ LEAD, 58CM MRI
• Common Device Name: NO MATCH
• 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: 24738736
• Report Number: 2017865-2026-06572
• Device Sequence Number: 14965581
• Product Code: NVN
• UDI-Device Identifier: 05415067046338
• UDI-Public: (01)05415067046338(10)P000233014(17)280430
• Combination Product (Y/N): N
• Initial Reporter Country: AS
• PMA/510(K) Number: P960013
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2026
• Device Explanted Year: 2026
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,User Facility,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 05/07/2026

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 Model Number: LPA1231/58
• Device Catalogue Number: LPA1231/58
• Device Lot Number: P000233014
• 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: 03/11/2026
• Supplement Date Received by Manufacturer: 04/29/2026
• Initial Report FDA Received Date: 03/31/2026
• Supplement Report FDA Received Date: 05/07/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 05/29/2025
• 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: ASSURITY MRI.; LPA1231/52 ULTIPACE.
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Unknown