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

Model Number PM2240

Device Problems Premature Discharge of Battery (1057); Pacing Problem (1439); Wireless Communication Problem (3283)

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

Event Date 03/31/2020

Event Type  Injury  

Event Description

It was reported that the patient presented to the emergency room for unrelated reasons.Upon interrogation, it was noted that the pacemaker exhibited telemetry lockout, premature battery depletion and inadequate pacing.It was noted that the patient was dependent.The pacemaker was explanted and replaced.Patient was stable throughout.

Manufacturer Narrative

Final analysis found an increased duty cycle of the internal circuitry caused by the firmware which resulted in a premature discharge of battery.

• Brand Name: ASSURITY RF DR
• Type of Device: IMPLANTABLE PACEMAKER PULSE GENERATOR
• Manufacturer (Section D): ST. JUDE MEDICAL, INC.(CRM-SYLMAR); 15900 valley view court; sylmar CA 91342
• MDR Report Key: 12502405
• MDR Text Key: 272439209
• Report Number: 2017865-2021-29917
• Device Sequence Number: 1
• Product Code: NVZ
• UDI-Device Identifier: 05414734507073
• UDI-Public: 05414734507073
• Combination Product (y/n): N
• PMA/PMN Number: P880086
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Type of Report: Initial,Followup
• Report Date: 10/25/2021

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: 02/28/2019
• Device Model Number: PM2240
• Device Catalogue Number: PM2240
• Device Lot Number: A000045023
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/22/2021
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 08/31/2021
• Initial Date FDA Received: 09/20/2021
• Supplement Dates Manufacturer Received: 10/18/2021
• Supplement Dates FDA Received: 10/25/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention