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

Model Number PM2240

Device Problem No Pacing (3268)

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

Event Date 10/09/2023

Event Type  malfunction  

Event Description

It was reported that the patient presented to the hospital for a scheduled implant procedure.During procedure, the pacemaker was unable to pace due to no pacing output.The pacemaker was removed and replaced on (b)(6) 2023.The patient was in stable condition throughout.

Manufacturer Narrative

The reported event of no pacing was not confirmed.The device was still in original shipping conditions upon receipt with battery voltage near beginning of life level.There were no measurements made on the device in the field.Electrical and mechanical evaluation, output parameters were within normal range.Additionally, visual inspection of the header and connector detected no contamination or foreign material that could contribute to the reported event.Longevity assessment performed, indicated normal range of operation with appropriate remaining longevity.No other anomalies were seen.

• 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: 18050265
• MDR Text Key: 327099426
• Report Number: 2017865-2023-50446
• Device Sequence Number: 1
• Product Code: NVZ
• UDI-Device Identifier: 05414734507073
• UDI-Public: 05414734507073
• Combination Product (y/n): N
• Reporter Country Code: CH
• PMA/PMN Number: P880086
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,User Facility,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 11/20/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/01/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: PM2240
• Device Lot Number: P000159827
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/23/2023
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 11/09/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 12/15/2022
• 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