MAUDE Adverse Event Report: ABBOTT ENDURITY¿ CORE DR, JPD; Pulse generator, permanent, implantable

Model Number PM2152

Device Problems Premature Discharge of Battery (1057); Incorrect Measurement (1383)

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

Event Date 03/13/2024

Event Type  Injury  

Event Description

It was reported that the device reached elective replacement indicator faster than expected.The physician alleged the event was due to premature battery depletion and a longevity overestimation by the merlin programmer.The device was explanted and replaced to resolve the event and the patient was in stable condition.

• 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: 19083830
• MDR Text Key: 339875396
• Report Number: 2017865-2024-38126
• Device Sequence Number: 1
• Product Code: NVZ
• UDI-Device Identifier: 05414734509770
• UDI-Public: (01)05414734509770(10)P000048062(17)190131
• 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
• Report Date: 04/10/2024

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 Expiration Date: 01/31/2019
• Device Model Number: PM2152
• Device Lot Number: P000048062
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 03/13/2024
• Initial Date FDA Received: 04/10/2024
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 07/27/2017
• 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