MAUDE Adverse Event Report: ST. JUDE MEDICAL, INC. CONFIRM RX; DETECTOR AND ALARM, ARRHYTHMIA

Model Number DM3500

Device Problems Defective Device (2588); Communication or Transmission Problem (2896)

Patient Problems Tissue Damage (2104); Palpitations (2467); Blood Loss (2597)

Event Date 01/17/2018

Event Type  malfunction  

Event Description

St.Jude confirm loop recorder inserted in ablation patient in electrophysiology (ep) lab.Device was unable to communicate/bluetooth malfunctioned (per device representative).Patient moved from ep lab to recovery.Confirm explanted by doctor and new device re-implanted in recovery.St.Jude rep present for both procedures.Procedural notes from initial implantation: local anesthesia was applied with 2% lidocaine/epinephrine.A small incision was made using the confirm rx loop delivery system and the loop device was inserted subcutaneously at the fourth intercostal space.Device sensing parameters were confirmed suitable at this time.The cutaneous incision was closed with 4-0 vicryl, dermabond, after which pressure was held on the incision site for five minutes.Excellent hemostasis was achieved.The confirm rx device was again confirmed to be sensing appropriately.The patient was given the trigger-monitoring device and taught its proper use.The patient was then discharged from the recovery area in excellent condition.Complications: no acute procedural complications.Estimated blood loss (ebl): 5cc.Fluoroscopy: 5mgy.Device data.Confirm rx.( procedural addendum **the loop recorder inserted lost bluetooth communication during programming of the device and was unable to be restored after multiple efforts by the team and tech services.The device was determined to be defective and therefore together we decided to remove the loop recorder and re-insert a new one.The procedure was conducted in the postoperative area.Procedure: removal of a defective implantable loop recorder.Re-implantation of a new patient-activated cardiac event recorder.The patient was positioned in the postop cath.Area in the non-sedated post-absorptive state.Continuous ekg monitoring was established.The patient was then prepped and draped in a sterile fashion.Local anesthesia was applied with 2% lidocaine/epinephrine.The previous incision was opened with a #15 blade and the defective loop easily removed.The pocket was irrigated with sterile saline.The new confirm rx loop delivery system and the loop device was inserted subcutaneously at the fourth intercostal space.Device sensing parameters were confirmed suitable at this time.The cutaneous incision was closed with 4-0 vicryl, dermabond, after which pressure was held on the incision site for five minutes.Excellent hemostasis was achieved.The confirm rx device was again confirmed to be sensing appropriately.The patient was given the trigger-monitoring device and taught its proper use.Complications: no acute procedural complications.Estimated blood loss: <5 cc.Specimens: none.Equipment specifics: generator: (b)(4).R waves 0.5mv.Impression: palpitations.Successful implantation of implantable loop recorder.

• Brand Name: CONFIRM RX
• Type of Device: DETECTOR AND ALARM, ARRHYTHMIA
• Manufacturer (Section D): ST. JUDE MEDICAL, INC.; 15900 valley view court; sylmar CA 91342
• MDR Report Key: 7218147
• MDR Text Key: 98223336
• Report Number: 7218147
• Device Sequence Number: 1
• Product Code: DSI
• UDI-Device Identifier: 05415067027320
• UDI-Public: (01)05415067027320(17)190408
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: User Facility
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 01/22/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Expiration Date: 04/08/2019
• Device Model Number: DM3500
• Device Catalogue Number: DM3500
• Other Device ID Number: (01)05415067027320(17)190408(
• Was Device Available for Evaluation?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 01/22/2018
• Event Location: Hospital
• Date Report to Manufacturer: 01/22/2018
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 01/25/2018
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Age: 68 YR
• Patient Weight: 78