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

Model Number PM2152

Device Problem Failure to Interrogate (1332)

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

Event Type  malfunction  

Event Description

It was reported, prior to an initial implant procedure, the device was unable to establish inductive telemetry.The device was not used.There were no patient consequences.

Manufacturer Narrative

Further information was requested but not received.

Manufacturer Narrative

The reported events of failure to interrogate, unable to program were not confirmed.The device was received from the field with battery voltage above elective replacement indicator (eri) level.Electrical and mechanical analysis performed indicated normal functionality.During the analysis the device was programmed to bipolar and unipolar modes normally.Additionally, evaluation of the header and connector found no contamination or foreign material that could contribute to the reported events.Longevity assessment was performed in the device was in normal range operation 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: 19208904
• MDR Text Key: 341331855
• Report Number: 2017865-2024-40004
• Device Sequence Number: 1
• Product Code: NVZ
• UDI-Device Identifier: 05414734509770
• UDI-Public: (01)05414734509770(10)P000195000(17)250831
• 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
• Report Date: 04/29/2024

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: P000195000
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 04/10/2024
• Initial Date FDA Received: 04/29/2024
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 02/29/2024
• 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