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

Model Number PM2152

Device Problem Incorrect, Inadequate or Imprecise Result or Readings (1535)

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

Event Date 07/04/2023

Event Type  malfunction  

Event Description

During an in clinic follow up, it was noted there was a missing egm from the device.The device was explanted and upgraded to an icd as indicated by the patient's condition, not due to the missing egm.The patient was stable.

Manufacturer Narrative

The reported event of ecg missing could not be confirmed.Additional field information was requested but was not available to verify the reported event.Device image analysis indicated segm directory was being cleared in the field.The device was received with normal output and telemetry communication.Analysis performed did not identify any functional issues.Longevity assessment found the device was operating above the elective replacement indicator (eri) voltage with appropriate remaining longevity.Additional findings: visual inspection of the header attachment area detected an anomaly between the pre-casted header and titanium case.Feedthrough leak test was performed, indicating no sign of hermeticity breach.A manufacturing process anomaly may have occurred, which resulted in the header bonding anomaly.

Manufacturer Narrative

The reported event of ecg missing could not be confirmed.The device was received with normal output and telemetry communication.Additional field information was requested but was not available to verify the reported event.Analysis performed did not identify any functional issues.Visual inspection and manufacturing investigation was performed to assess the pre-casted header, which determined its condition is acceptable and not potentially causing any functional issue to the device.Longevity assessment found the device was operating above the elective replacement indicator (eri) voltage with appropriate remaining longevity.

• 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: 17428492
• MDR Text Key: 320115076
• Report Number: 2017865-2023-37109
• 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: 11/21/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/31/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 05/31/2023
• Device Model Number: PM2152
• Device Lot Number: P000135596
• 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: 11/09/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 11/13/2021
• 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