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

Model Number PM2152

Device Problem Data Problem (3196)

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

Event Date 10/26/2023

Event Type  malfunction  

Event Description

It was reported that the data on the device appeared to be corrupted on the merlin programmer prior to the implant procedure.The device was not used and a new device was implanted to resolve the event.The patient was in stable condition.

Manufacturer Narrative

The reported event of data problem was confirmed.The device voltage was above elective replacement indicator (eri) voltage level upon receipt.Analysis of the device image indicated device was within normal range of operation.Further analysis indicated strange inscriptions noted in the field was due to patient information data having non-zero value on a shipped set device.This resulted into the data problem reported by the field.

• 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: 18145090
• MDR Text Key: 328223141
• Report Number: 2017865-2023-52576
• Device Sequence Number: 1
• Product Code: NVZ
• Combination Product (y/n): N
• Reporter Country Code: IT
• 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: 02/28/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: PM2152
• Device Lot Number: P000173092
• 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: Not provided
• Initial Date FDA Received: 11/15/2023
• Supplement Dates Manufacturer Received: 02/08/2024
• Supplement Dates FDA Received: 02/28/2024
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 06/16/2023
• 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