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

Model Number PM1272

Device Problems Migration or Expulsion of Device (1395); Capturing Problem (2891)

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

Event Type  Injury  

Event Description

It was reported that the patient presented in clinic for follow-up.Upon interrogation, it was found that the pacemaker exhibited increased capture threshold.Chest x-ray was performed and confirmed that the device had migrated with twiddler's syndrome.The pacemaker was explanted and replaced.Patient condition was stable.

Manufacturer Narrative

Reported event of inadequate capture was not confirmed.The device above elective replacement indicator (eri) level was returned in one piece for analysis.Longevity assessment, output verification, capture test, and inspection of header and connectors were normal with no anomalies found.

• Brand Name: ASSURITY MRI
• 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: richard williamson ; 15900 valley view court; sylmar, CA 91342
• MDR Report Key: 16958071
• MDR Text Key: 315527969
• Report Number: 2017865-2023-20457
• Device Sequence Number: 1
• Product Code: LWP
• UDI-Device Identifier: 05414734509572
• UDI-Public: 05414734509572
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: P140033
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,User Facility
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 06/22/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/18/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 09/30/2023
• Device Model Number: PM1272
• Device Catalogue Number: PM1272
• Device Lot Number: A000122308
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/01/2023
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 06/08/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 03/08/2022
• 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
• Treatment: RV LEAD
• Patient Outcome(s): Required Intervention
• Patient Age: 90 YR
• Patient Sex: Female
• Patient Weight: 59 KG