MAUDE Adverse Event Report: ABBOTT ENDURITY¿ CORE SR, JPD; PULSE GENERATOR, PERMANENT, IMPLANTABLE

Model Number PM1152

Device Problems Failure to Capture (1081); Failure to Sense (1559)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 10/28/2022

Event Type  malfunction  

Event Description

During the initial implant procedure, the device was connected to the leads, sensing and capture threshold were not measurable.The device was disconnected and upon reconnection with the leads, the measurements were still not possible.A new device was selected and measurements were performed properly.The patient was stable.

Manufacturer Narrative

The pacer was received from the field with battery voltage above elective replacement indicator (eri) level.Electrical and mechanical analysis performed indicated normal functionality, and capture test performed under nominal conditions found no anomaly.Further evaluation of sensing performance at most sensitive level was within normal range.Additionally, visual inspection of the header and connectors detected no contamination or foreign material that could contribute to the reported events.Longevity assessment was performed, and the device was in normal rage of operation with appropriate remaining longevity.

• Brand Name: ENDURITY¿ CORE SR, JPD
• Type of Device: 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: richard williamson ; 15900 valley view court; sylmar, CA 91342
• MDR Report Key: 18452281
• MDR Text Key: 332372619
• Report Number: 2017865-2024-00444
• Device Sequence Number: 1
• Product Code: NVZ
• Combination Product (y/n): N
• Reporter Country Code: GM
• PMA/PMN Number: P880086
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 02/12/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/05/2024
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 12/31/2023
• Device Model Number: PM1152
• Device Lot Number: P000149579
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 01/25/2024
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 06/21/2022
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1