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

Model Number PM2152

Device Problems High impedance (1291); Difficult to Insert (1316); Failure to Sense (1559); Connection Problem (2900)

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

Event Date 08/29/2023

Event Type  Injury  

Event Description

It was reported that a high pacing impedance and a loss of sensing were observed on the device.A revision procedure was performed and the physician experienced difficulty when re-connecting the device and the right atrial (ra) lead, but was able to successfully reconnect.The cause of the high pacing impedance and loss of sensing was suspected to be due to an inadequate insertion of the ra lead into the device.The patient was stable and will continue to be monitored.

Manufacturer Narrative

A device history record (dhr) review was performed and all required manufacturing processes and inspections steps were confirmed to be completed per the requirements.The device met specifications prior to leaving abbott manufacturing facilities.

• 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: 17683532
• MDR Text Key: 322641436
• Report Number: 2017865-2023-41006
• 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: 11/14/2023

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: P000173044
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 08/29/2023
• Initial Date FDA Received: 09/05/2023
• Supplement Dates Manufacturer Received: 11/14/2023
• Supplement Dates FDA Received: 11/14/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 06/15/2023
• 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