MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION LATITUDE PROGRAMMING SYSTEM; EXTERNAL PROGRAMMER

Model Number	3300
Medical Device Problem Code	Interrogation Problem (4017)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/19/2024
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that the patient with a implantable cardioverter defibrillator (icd) was to undergo a magnetic resonance imaging (mri) so it was to be programmed into mri protection mode.The pacemaker was not able to be interrogate with the programmer, with it displaying a wand out of range message.Technical services (ts) performed troubleshooting, with the issue not resolved so the caller was advised to contact their local field representative.This device remains in service.No adverse patient effects were reported.
Event or Problem Description
It was reported that the patient with a implantable cardioverter defibrillator (icd) was to undergo a magnetic resonance imaging (mri) so it was to be programmed into mri protection mode.The pacemaker was not able to be interrogate with the programmer, with it displaying a wand out of range message.Technical services (ts) performed troubleshooting, with the issue not resolved so the caller was advised to contact their local field representative.This device remains in service.No adverse patient effects were reported.Additional information from the field indicates the issue was resolved, a new programmer and a new wand was used and it was able to interrogate the icd.The issues were attributed to damage in the wand.This device remains in service.No adverse patient effects were reported.

• Brand Name: LATITUDE PROGRAMMING SYSTEM
• Common Device Name: EXTERNAL PROGRAMMER
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; 4100 hamline avenue north; saint paul MN 55112
• Manufacturer (Section G): PLEXUS ELECTRONICA S DE RL DE CV; paseo del norte no; 4640 guadalajara; zapopan, jal 45010 ; MX 45010
• Manufacturer Contact: timothy degroot ; 4100 hamline avenue north; saint paul, MN 55112 ; 6515826168
• MDR Report Key: 20428957
• Report Number: 2124215-2024-63669
• Device Sequence Number: 12862566
• Product Code: OSR
• UDI-Device Identifier: 00802526610110
• UDI-Public: 00802526610110
• Combination Product (Y/N): N
• Initial Reporter State: IL
• Initial Reporter Country: US
• PMA/510(K) Number: P910077/S159
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 10/14/2024

1 Device was Involved in the Event

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 Model Number: 3300
• Device Catalogue Number: 3300
• Device Lot Number: 010960
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/19/2024
• Supplement Date Received by Manufacturer: 10/11/2024
• Initial Report FDA Received Date: 10/11/2024
• Supplement Report FDA Received Date: 10/14/2024
• Is the Device Labeled for Single Use? (Y/N): No
• 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