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
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: 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
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