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

Model Number 5386

Device Problems Pacing Problem (1439); Failure to Disconnect (2541); Contamination of Device Ingredient or Reagent (2901)

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

Event Date 10/19/2021

Event Type  malfunction  

Event Description

Related manufacturer reference number: 2017865-2021-36074.It was reported that the dependent patient presented for on (b)(6) 2021 for routine change of the pulse generator.Upon interrogation, it was noted that the right ventricular lead exhibited elevated capture threshold and low pacing impedance.The setscrew of the device would not engage with the screwdriver and was observed to be clogged with a substance that was removed by the physician.During the procedure the device stopped pacing after electrocautery was used.The lead was capped and replaced, and device was successfully exchanged.The patient was in stable condition.

Manufacturer Narrative

The reported events of failure to disconnect and contamination of device ingredient or reagent could not be confirmed.Analysis for setscrew, septum, and wrench were not performed as they were not returned.Device was received in backup operation mode due to exposure to electrocautery.Electrical testing was performed, and no anomalies were noted.X-ray examination and visual inspection did not find any anomalies.Longevity assessment was performed and device exceeded the expected longevity.

• Brand Name: IDENTITY ADX XL DR
• 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: 12771624
• MDR Text Key: 280472782
• Report Number: 2017865-2021-36073
• Device Sequence Number: 1
• Product Code: DXY
• UDI-Device Identifier: 05414734006903
• UDI-Public: 05414734006903
• 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,Followup
• Report Date: 12/28/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/08/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 10/31/2010
• Device Model Number: 5386
• Device Catalogue Number: 5386
• Device Lot Number: 2834520
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/25/2021
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 12/08/2021
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 04/15/2009
• 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: TENDRIL SDX LEAD
• Patient Age: 71 YR
• Patient Sex: Male
• Patient Weight: 88 KG