MAUDE Adverse Event Report: BENCHMARK ZOOM LATITUDE; EXTERNAL PROGRAMMER

Model Number	3120
Medical Device Problem Codes	Application Program Problem (2880); Interrogation Problem (4017)
Health Effect - Clinical Codes	Presyncope (4410); Syncope/Fainting (4411)
Date of Event	01/06/2021
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
If information is provided in the future, a supplemental report will be issued.
Event or Problem Description
It was reported that this patient underwent left ventricular (lv) threshold testing, but the health care professional (hcp) was unable to terminate the threshold test.The device recorded greater than two seconds of asystole, and a later report noted greater than ten seconds of asystole.The patient had symptoms of near fainting.The programmer exhibited an error message.After this, lv threshold testing was stopped, and the check was completed.One report noted that stat pace was pressed, but another report noted it was not pressed.Device data was preserved and submitted for boston scientific engineering review.Engineering analysis showed they were unable to determine the root cause of why the message was displayed, but it was indicative of poor telemetry or telemetry noise.No additional adverse patient effects were reported.
Additional Manufacturer Narrative
If information is provided in the future, a supplemental report will be issued.
Event or Problem Description
It was reported that this patient underwent left ventricular (lv) threshold testing, but the health care professional (hcp) was unable to terminate the threshold test.The device recorded greater than two seconds of asystole, and a later report noted greater than ten seconds of asystole.The patient had symptoms of near fainting.The programmer exhibited an error message.After this, lv threshold testing was stopped, and the check was completed.One report noted that stat pace was pressed, but another report noted it was not pressed.Device data was preserved and submitted for boston scientific engineering review.Engineering analysis showed they were unable to determine the root cause of why the message was displayed, but it was indicative of poor telemetry or telemetry noise.No additional adverse patient effects were reported.Additional information was received which reported that the patient experienced syncope with the previously reported issues.It was also noted that there was not greater than ten seconds of asystole, and that stat pace was pressed, which was successful.No additional adverse patient effects were reported.

• Brand Name: ZOOM LATITUDE
• Common Device Name: EXTERNAL PROGRAMMER
• Manufacturer (Section D): BENCHMARK; 4065 theurer boulevard; winona MN 55987
• MDR Report Key: 11369570
• Report Number: 2124215-2021-03824
• Device Sequence Number: 3711736
• Product Code: LWS
• UDI-Device Identifier: 00802526564703
• UDI-Public: 00802526564703
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• 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: foreign,health professional
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 03/23/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Model Number: 3120
• Device Catalogue Number: 3120
• Device Lot Number: 073717
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 01/06/2021
• Supplement Date Received by Manufacturer: 02/22/2021
• Initial Report FDA Received Date: 02/23/2021
• Supplement Report FDA Received Date: 03/23/2021
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Life Threatening