MAUDE Adverse Event Report: EXTERNAL MANUFACTURER ZOOM

Model Number	3120
Medical Device Problem Code	Pacing Problem (1439)
Health Effect - Clinical Code	Syncope (1610)
Date of Event	10/03/2017
Type of Reportable Event	Serious Injury
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, complete threshold testing was performed multiple times when ending the test before it was completed, exiting the test with mics antenna and pressing the stat pace button while interrogating a pacemaker.All testing was successful with no issues noted.Laboratory testing was unable to reproduce the reported clinical observations.As no further information concerning this report is expected, our investigation is complete.This investigation will be updated should further information be provided.
Event or Problem Description
Boston scientific received information that during pacing threshold testing, at the point of loss of capture, this programmer did not end the testing for approximately four seconds.There was a four second pause in pacing which resulted in a syncopal event for this patient.It was noted that the programmer had a frayed power cord and it was subsequently removed from service and returned.No additional adverse patient effects were reported.

• Brand Name: ZOOM
• Manufacturer (Section D): EXTERNAL MANUFACTURER
• MDR Report Key: 7070247
• Report Number: 2124215-2017-20559
• Device Sequence Number: 13732832
• Product Code: LWS
• UDI-Device Identifier: 00802526579707
• UDI-Public: 00802526579707
• Combination Product (Y/N): N
• Initial Reporter State: WA
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative
• Initial Reporter Occupation: Medical Equipment Company Technician/Representative
• Type of Report: Initial
• Report Date (Section B): 10/03/2017

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: Lay User/Patient
• Device Model Number: 3120
• Other Device ID Number: ZOOM LATITUDE PROGRAMMER
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/23/2017
• Was the Report Sent to FDA?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/03/2017
• Initial Report FDA Received Date: 11/30/2017
• 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: 0296; 4136; 4555; N160
• Outcome Attributed to Adverse Event: Life Threatening; Other
• Patient Age: 57 YR