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

Model Number PM2152

Device Problems Failure to Interrogate (1332); No Pacing (3268)

Patient Problems Dyspnea (1816); Dizziness (2194); No Clinical Signs, Symptoms or Conditions (4582)

Event Date 02/28/2024

Event Type  Injury  

Event Description

It was reported that the device exhibited a loss of pacing resulting in dizziness and dyspnea and was unable to be interrogated.The device was explanted and replaced.The patient was stable.

• 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: 18906169
• MDR Text Key: 337691048
• Report Number: 2017865-2024-35026
• 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: 03/28/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/14/2024
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 06/30/2021
• Device Model Number: PM2152
• Device Lot Number: P000096112
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 03/28/2024
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 01/03/2020
• 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