MAUDE Adverse Event Report: EXTERNAL MANUFACTURER ZOOM

Model Number	3120
Medical Device Problem Codes	Failure to Capture (1081); Device Operates Differently Than Expected (2913); Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Complaint, Ill-Defined (2331)
Date of Event	05/10/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The product has been received for analysis.This report will be updated upon completion of analysis.
Event or Problem Description
Boston scientific received information that, after the end test button was pressed, this programmer/recorder/monitor (prm) took four seconds to end the manual left ventricular (lv) threshold test that was in progress.During this time, the resulting loss of capture led to the patient having a near-syncopal episode.Pacing inhibition of up to three seconds was reported.This prm remains in service.Boston scientific technical services (ts) discussed other ways to end testing.This prm was returned for analysis.The implanted system remains in service.
Additional Manufacturer Narrative
Upon receipt, the programmer underwent functional testing.The programmer was powered on to check for error reports or boot-up issues.No anomalies were noted.Next, a test device was interrogated several times, confirming there were no communication problems between the device and programmer.Additionally, the touch screen was checked for functionality and calibration, with no issues noted.Laboratory testing was unable to reproduce the reported clinical observations and detailed analysis did not reveal any abnormalities other than a scratched external housing, which was replaced.The programmer performed normally throughout all tests.

• Brand Name: ZOOM
• Manufacturer (Section D): EXTERNAL MANUFACTURER
• MDR Report Key: 7650541
• Report Number: 2124215-2018-11119
• Device Sequence Number: 14056559
• Product Code: LWS
• UDI-Device Identifier: 00802526582004
• UDI-Public: 00802526582004
• Combination Product (Y/N): N
• Initial Reporter State: HI
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: health professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 07/29/2018

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: Other
• Device Model Number: 3120
• Other Device ID Number: ZOOM LATITUDE PROGRAMMER
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/13/2018
• Was the Report Sent to FDA?: Yes
• Initial Date Received by Manufacturer: 05/10/2018
• Supplement Date Received by Manufacturer: 07/29/2018
• Initial Report FDA Received Date: 06/29/2018
• Supplement Report FDA Received Date: 10/08/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: 1888TC; MISMATCH; V173
• Patient Age: 76 YR