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

Model Number PM2152

Device Problems Premature Discharge of Battery (1057); Failure to Interrogate (1332)

Patient Problems Dizziness (2194); Syncope/Fainting (4411)

Event Date 03/29/2024

Event Type  Injury  

Event Description

It was reported that the patient presented into the emergency room with dizziness and syncope.The device was unable to be interrogated and did not respond to a magnet.The alleged cause of the event was due to premature battery depletion of the device.The device was explanted and replaced to resolve the event.The patient was stable and will continue to be monitored.

Manufacturer Narrative

The reported events of premature discharge of battery, inability to interrogate, and no magnet response were confirmed.The device was received with no telemetry communication and no output.Visual inspection of the header attachment area detected an anomaly between the pre-cast header and titanium case.The device was cut open to enable further testing and the battery was found depleted.A feedthrough leak test was performed, indicating a device hermeticity breach.This is consistent with feedthrough damage as a result of fluid intrusion between the header and case, and subsequent fluid ingress to internal electronics.Hybrid circuitry was tested by connecting to an external power source.Test results indicated elevated current drain, consistent with moisture damage, resulting in the reported event.A manufacturing process anomaly consistent with header bonding anomaly may have occurred.

• 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: 19050379
• MDR Text Key: 339477287
• Report Number: 2017865-2024-37786
• Device Sequence Number: 1
• Product Code: NVZ
• UDI-Device Identifier: 05414734509770
• UDI-Public: (01)05414734509770(10)P000095294(17)210630
• Combination Product (y/n): N
• Reporter Country Code: GR
• 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: 04/05/2024

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: 06/30/2021
• Device Model Number: PM2152
• Device Lot Number: P000095294
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 03/29/2024
• Initial Date FDA Received: 04/05/2024
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 12/20/2019
• 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; Hospitalization