MAUDE Adverse Event Report: ST. JUDE MEDICAL, INC.(CRM-SYLMAR) ASSURITY MRI; IMPLANTABLE PACEMAKER PULSE GENERATOR

Model Number PM2272

Device Problems Premature Discharge of Battery (1057); Difficult to Interrogate (1331); Interrogation Problem (4017)

Patient Problems No Consequences Or Impact To Patient (2199); No Clinical Signs, Symptoms or Conditions (4582)

Event Date 09/28/2020

Event Type  Injury  

Manufacturer Narrative

The results/method and conclusion codes along with investigation results will be provided in the final report.

Event Description

It was reported that the patient presented in clinic for routine device check.Interrogation was noted to be prolonged.It was found that the patient's pacemaker had been in end of service (eos) status unexpectedly.Premature depletion was alleged on the device.The device was explanted and replaced.The patient was stable.

Manufacturer Narrative

The field complaint of premature battery depletion was confirmed.Final analysis found a battery anomaly in which elevated current drain from the hybrid circuitry resulted in end-of-life status earlier than the projected longevity of the device.

Manufacturer Narrative

The reported event of premature battery depletion was confirmed and interrogation problem was not confirmed.Final analysis found unknown high leakage current for nine months.Device image was retrieved and analyzed, indicating elevated current within a period of the implant duration due to the duty cycle of the internal circuitry caused by a firmware anomaly.Additional testing indicated normal device functionality and high current condition could non-reproducible.

• Brand Name: ASSURITY MRI
• Type of Device: IMPLANTABLE PACEMAKER PULSE GENERATOR
• 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: sonali arangil ; 15900 valley view court; sylmar, CA 91342
• MDR Report Key: 10683822
• MDR Text Key: 211474663
• Report Number: 2017865-2020-15526
• Device Sequence Number: 1
• Product Code: LWP
• UDI-Device Identifier: 05414734509589
• UDI-Public: 05414734509589
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: P140033
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,User Facility,Company Representative
• Reporter Occupation: Nurse
• Type of Report: Initial,Followup,Followup
• Report Date: 02/07/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/15/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 12/31/2018
• Device Model Number: PM2272
• Device Catalogue Number: PM2272
• Device Lot Number: A000042042
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/06/2020
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 02/04/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 06/28/2017
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Sex: Female