MAUDE Adverse Event Report: ST. JUDE MEDICAL, INC.(CRM-SYLMAR) ASSURITY RF DR; Pulse generator, permanent, implantable

Model Number PM2240

Device Problem Premature Discharge of Battery (1057)

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

Event Date 04/10/2024

Event Type  Injury  

Event Description

Following the electronics performance indicator (epi), an alert was received by the clinician and device was explanted.The patient condition was stable before, during and after the procedure.

Manufacturer Narrative

The reported event of premature discharge of battery was not confirmed.The device was received from the field with battery voltage above elective replacement indicator (eri) level.Visual inspection of the header found no anomaly related to the field concern.Electrical and mechanical analysis performed indicated normal functionality.Further battery assessment at various pulse amplitudes found current level within normal range and no indication of premature depletion noted.Longevity assessment was performed based on average drain current and the device was in normal range of operation with appropriate remain longevity.

• Brand Name: ASSURITY RF DR
• Type of Device: Pulse generator, permanent, implantable
• Manufacturer (Section D): ST. JUDE MEDICAL, INC.(CRM-SYLMAR); 15900 valley view court; sylmar CA 91342
• Manufacturer (Section G): ST. JUDE MEDICAL, INC.(CRM-SYLMAR); 15900 valley view court; sylmar CA 91342
• Manufacturer Contact: richard williamson ; 15900 valley view court; sylmar, CA 91342
• MDR Report Key: 19175411
• MDR Text Key: 340957498
• Report Number: 2017865-2024-39531
• Device Sequence Number: 1
• Product Code: NVZ
• UDI-Device Identifier: 05414734507073
• UDI-Public: (01)05414734507073(10)A000003539(17)160930
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: P880086
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,User Facility,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 04/24/2024

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: 09/30/2016
• Device Model Number: PM2240
• Device Lot Number: A000003539
• 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: 04/24/2024
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 03/20/2015
• 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
• Treatment: 1888TC/46 TENDRIL; 1888TC/52CM TENDRIL
• Patient Outcome(s): Required Intervention
• Patient Age: 80 YR
• Patient Sex: Female
• Patient Weight: 73 KG