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

Model Number CD1411-36C

Device Problems Signal Artifact/Noise (1036); No Apparent Adverse Event (3189)

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

Event Type  malfunction  

Event Description

It was reported that the pacemaker exhibited noise.No intervention was performed.

Manufacturer Narrative

Further information was requested but not received.

Manufacturer Narrative

Correction: product model should have been cd1411-36c, rather than pm2272; patient identifier should have been kk, rather than afh.

Manufacturer Narrative

Correction: upon review the implantable cardioverter defibrillator (icd), manufacturer report 2017865-2024-00854, should not have been submitted as a medical device report (mdr) as there was no allegation of malfunction on the icd.

• Brand Name: ASSURITY MRI
• Type of Device: IMPLANTABLE PULSE GENERATOR, PACEMAKER (NON-CRT)
• 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: 18481722
• MDR Text Key: 332528248
• Report Number: 2017865-2024-00854
• Device Sequence Number: 1
• Product Code: NVZ
• UDI-Device Identifier: 05414734507707
• UDI-Public: 05414734507707
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: P910023
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Company Representative
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup,Followup
• Report Date: 01/16/2024
• 2 Devices were Involved in the Event: 1 2

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: CD1411-36C
• Device Lot Number: A000136504
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 12/19/2023
• Initial Date FDA Received: 01/10/2024
• Supplement Dates Manufacturer Received: 12/19/2023; 01/11/2024
• Supplement Dates FDA Received: 01/12/2024; 01/16/2024
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 07/13/2018
• 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: MRI CONDTENDRIL LEAD.; MRI CONDTENDRIL LEAD.
• Patient Age: 86 YR
• Patient Sex: Male