MAUDE Adverse Event Report: ST. JUDE MEDICAL, INC.(CRM-SYLMAR) QUADRA ALLURE MP CRT-P; IMPLANTABLE PACEMAKER PULSE GENERATOR

Model Number PM3562

Device Problems Failure to Interrogate (1332); Interrogation Problem (4017)

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

Event Date 12/10/2021

Event Type  Injury  

Event Description

Related manufacturer reference numbers: 2017865-2021-39810.It was reported that the patient presented in clinic for follow-up.Upon interrogation, it was found that the right ventricular (rv) lead had increased capture threshold.Rv lead dislodgement was suspected.It was also noted that the pacemaker (pm) exhibited slow radio frequency (rf) telemetry and it was difficult to program the pm.Patient presented in clinic for rv lead revision.Upon interrogation prior to procedure, it was found that pm had no rf telemetry.The pm and the rv lead were both explanted and replaced.Patient condition was stable.

Manufacturer Narrative

Correction - e1 - reporter address line 1 should have been "399 bathurst st" rather than being empty.

Manufacturer Narrative

The reported event of device unable to be interrogated was not confirmed.The device with battery voltage in normal range was returned for analysis.Analysis, interrogation testing and longevity assessment were normal with no anomalies found.

• Brand Name: QUADRA ALLURE MP CRT-P
• 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: 13054764
• MDR Text Key: 282584074
• Report Number: 2017865-2021-39809
• Device Sequence Number: 1
• Product Code: NKE
• UDI-Device Identifier: 05414734510097
• UDI-Public: 05414734510097
• Combination Product (y/n): N
• Reporter Country Code: CA
• PMA/PMN Number: P030035
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,User Facility,Company Representative
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup,Followup
• Report Date: 03/09/2022

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: 09/30/2022
• Device Model Number: PM3562
• Device Catalogue Number: PM3562
• Device Lot Number: P000119560
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/02/2022
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 12/21/2021
• Initial Date FDA Received: 12/21/2021
• Supplement Dates Manufacturer Received: 12/21/2021; 02/23/2022
• Supplement Dates FDA Received: 12/21/2021; 03/09/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 03/16/2021
• 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
• Patient Outcome(s): Required Intervention