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

Model Number PM2152

Device Problems High impedance (1291); Defective Device (2588)

Patient Problem Hematoma (1884)

Event Date 12/13/2023

Event Type  Injury  

Event Description

It was reported that an increase in the pacing impedance was observed on the device.Additionally, a hematoma was formed on the patient.As a result, the device was explanted and replaced to resolve the event.The cause of the event was alleged to be due to a suspected header anomaly.The patient was explanted and replaced to resolve the event.

Manufacturer Narrative

The reported event of high atrial impedance was confirmed.Analysis revealed the atrial contact spring was missing from the ring slot of the atrial connector port which resulted in the high atrial impedance.The connector port dimensions were normal.No device anomalies were revealed except for the missing spring.The missing spring was due to a manufacturing anomaly.

• Brand Name: ENDURITY¿ CORE DR, 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: 18446725
• MDR Text Key: 332144815
• Report Number: 2017865-2024-00374
• 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: 05/31/2024

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
• Device Operator: Health Professional
• Device Model Number: PM2152
• Device Lot Number: P000184478
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 12/28/2023
• Initial Date FDA Received: 01/04/2024
• Supplement Dates Manufacturer Received: 09/23/2015
• Supplement Dates FDA Received: 05/31/2024
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 10/26/2023
• 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
• Patient Outcome(s): Required Intervention