MAUDE Adverse Event Report: EXTERNAL MANUFACTURER ZOOM

Model Number	3120
Medical Device Problem Code	Device Operates Differently Than Expected (2913)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	10/05/2017
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Upon receipt at our post market quality assurance laboratory, analysis revealed that this programmer's inverter was shorted and the inverter and liquid crystal display covers were melted.The affected parts were replaced and the programmer passed all functional and incoming tests.
Event or Problem Description
Boston scientific received information that this programmer's screen went black and was no longer functioning.The programmer was repaired.No adverse patient effects were reported.

• Brand Name: ZOOM
• Manufacturer (Section D): EXTERNAL MANUFACTURER
• MDR Report Key: 7070249
• Report Number: 2124215-2017-21770
• Device Sequence Number: 944455
• Product Code: LWS
• UDI-Device Identifier: 00802526582004
• UDI-Public: 00802526582004
• Combination Product (Y/N): N
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 11/16/2017

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: 10/26/2017
• Was the Report Sent to FDA?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/16/2017
• 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