MAUDE Adverse Event Report: BENCHMARK ZOOM LATITUDE; EXTERNAL PROGRAMMER

Model Number	3120
Medical Device Problem Codes	Unexpected Therapeutic Results (1631); Material Integrity Problem (2978)
Health Effect - Clinical Codes	Dizziness (2194); Malaise (2359); Asystole (4442)
Date of Event	08/25/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The product is expected to be returned for analysis.This report will be updated upon return and completion of analysis.
Event or Problem Description
It was reported that during a device follow-up, the physician performed a threshold test.However, the pacemaker-dependent patient went into asystole, with dizziness and malaise.The programmer touchscreen would not respond so the physician could not stop the test immediately.The patient recovered with no intervention or additional adverse effects.The programmer will be returned for analysis and repair.
Additional Manufacturer Narrative
The product is expected to be returned for analysis.This report will be updated upon return and completion of analysis.This correction report is being filed to add the asystole patient code that was missed in the initial report.The product has been received for analysis.This report will be updated upon completion of analysis.
Event or Problem Description
It was reported that during a device follow-up, the physician performed a threshold test.However, the pacemaker-dependent patient went into asystole, with dizziness and malaise.The programmer touchscreen would not respond so the physician could not stop the test immediately.The patient recovered with no intervention or additional adverse effects.The programmer will be returned for analysis and repair.
Additional Manufacturer Narrative
The product is expected to be returned for analysis.This report will be updated upon return and completion of analysis.This correction report is being filed to add the asystole patient code that was missed in the initial report.The product has been received for analysis.This report will be updated upon completion of analysis.The programmer was returned for repair.Analysis was not performed as the failure modes are well understood, are not increasing, and are expected to stay the same for the remaining units that are still in service.This model is no longer being manufactured and there are no planned design changes.Therefore, an evaluation conclusion code of cause not established was assigned.
Event or Problem Description
It was reported that during a device follow-up, the physician performed a threshold test.However, the pacemaker-dependent patient went into asystole, with dizziness and malaise.The programmer touchscreen would not respond so the physician could not stop the test immediately.The patient recovered with no intervention or additional adverse effects.The programmer will be returned for analysis and repair.

• Brand Name: ZOOM LATITUDE
• Common Device Name: EXTERNAL PROGRAMMER
• Manufacturer (Section D): BENCHMARK; 4065 theurer boulevard; winona MN 55987
• Manufacturer (Section G): BOSTON SCIENTIFIC; 4100 hamline avenue north; saint paul MN 55112
• Manufacturer Contact: timothy degroot ; 4100 hamline avenue north; saint paul, MN 55112 ; 6515826168
• MDR Report Key: 12756325
• Report Number: 2124215-2021-34522
• Device Sequence Number: 11843873
• Product Code: LWS
• UDI-Device Identifier: 00802526564703
• UDI-Public: 00802526564703
• Combination Product (Y/N): N
• Initial Reporter Country: BR
• PMA/510(K) Number: P910077/S046
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Other,Foreign,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 05/03/2023

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: 3120
• Device Catalogue Number: 3120
• Device Lot Number: 077153
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 08/25/2021
• Supplement Date Received by Manufacturer: 11/28/2022; 04/10/2023
• Initial Report FDA Received Date: 11/07/2021
• Supplement Report FDA Received Date: 12/21/2022; 05/03/2023
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 03/26/2011
• Is the Device Labeled for Single Use? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown