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 Patient Involvement (2645)
Date of Event	09/11/2017
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 this programmer exhibited electrical shortage and emitted smoke.The programmer will be returned.There was no patient involvement reported.
Additional Manufacturer Narrative
Upon receipt at our post market quality assurance laboratory, this programmer was thoroughly inspected and analyzed.The programmer was confirmed to exhibit a product performance issue.The programmer was opened in order to assess the internal components.Detailed inspection identified an internal electrical component that showed printed circuit board (pcb) was burned and partially shorted resulting in the reported clinical observations.
Event or Problem Description
Boston scientific received information that this programmer exhibited electrical shortage and emitted smoke.The programmer was repaired.No adverse patient effects were reported.

• Brand Name: ZOOM
• Manufacturer (Section D): EXTERNAL MANUFACTURER
• MDR Report Key: 6995742
• Report Number: 2124215-2017-20163
• Device Sequence Number: 1354038
• Product Code: LWS
• UDI-Device Identifier: 00802526582004
• UDI-Public: 00802526582004
• Combination Product (Y/N): N
• Initial Reporter State: VA
• 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,Followup
• Report Date (Section B): 12/31/2017

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: 09/26/2017
• Was the Report Sent to FDA?: Yes
• Initial Date Received by Manufacturer: 09/11/2017
• Supplement Date Received by Manufacturer: 12/31/2017
• Initial Report FDA Received Date: 11/02/2017
• Supplement Report FDA Received Date: 01/25/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1