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

Model Number	PM2260
Medical Device Problem Codes	Failure to Interrogate (1332); Interrogation Problem (4017)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/03/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Correction: previously need to include the expiration date on jul 31, 2016, and the date for device manufacture in h4 section on jan 7, 2015.
Additional Manufacturer Narrative
Further information was requested but not received.
Event or Problem Description
It was reported that the pacemaker exhibited failure to interrogate- no magnet response.No intervention was reported.The patient was in stable condition.
Additional Manufacturer Narrative
Correction: h6 section: previous report should have mentioned interrogation problem instead of failure to interrogate.
Event or Problem Description
It was reported that the pacemaker exhibited interrogation problem-inappropriate magnet response.No intervention was reported.The patient was in stable condition.
Additional Manufacturer Narrative
Correction: d4 section for primary unique device identification (udi) number.

• Brand Name: ASSURITY + DR RF
• Common Device Name: 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: 19356864
• Report Number: 2017865-2024-42009
• Device Sequence Number: 14395374
• Product Code: NVZ
• UDI-Device Identifier: 05414734507097
• UDI-Public: (01)05414734507097(10)P000000245(17)160731
• Combination Product (Y/N): N
• Initial Reporter Country: CA
• PMA/510(K) Number: P880086
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2015
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,User Facility,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup,Followup,Followup,Followup
• Report Date (Section B): 06/12/2024
• 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
• Operator of Device: Health Professional
• Device Expiration Date: 07/31/2016
• Device Model Number: PM2260
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/03/2024
• Supplement Date Received by Manufacturer: 05/23/2024; 05/26/2024; 05/31/2024; 05/31/2024
• Initial Report FDA Received Date: 05/21/2024
• Supplement Report FDA Received Date: 05/23/2024; 05/28/2024; 05/30/2024; 06/11/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 01/07/2015
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown