MAUDE Adverse Event Report: BENCHMARK ZOOM LATITUDE; PROGRAMMER

Model Number	3120
Medical Device Problem Code	Defective Device (2588)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	03/19/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
At this time, the product has not been returned.If the product is returned, analysis will be performed and this report would be updated at that time.
Event or Problem Description
Boston scientific received information that the programmer started smoking and smelled burnt upon interrogating a patient.The field representative will return the programmer back.No adverse patient effects were reported.
Additional Manufacturer Narrative
Upon receipt at our post market quality assurance laboratory, the allegation against the programmer was not confirmed.There were no external signs of abuse or drop damage.The programmer was in good condition and did not require external parts replaced.There were also no signs of burned components on any of the pcba's or power supply.The programmer passed all baseline checks and all incoming analysis.
Event or Problem Description
Boston scientific received information that the programmer started smoking and smelled burnt upon interrogating a patient.The field representative will return the programmer back.No adverse patient effects were reported.

• Brand Name: ZOOM LATITUDE
• Common Device Name: PROGRAMMER
• Manufacturer (Section D): BENCHMARK; 4065 theurer boulevard; winona MN 55987
• MDR Report Key: 8581825
• Report Number: 2124215-2019-08904
• Device Sequence Number: 1655014
• Product Code: LWS
• UDI-Device Identifier: 00802526575303
• UDI-Public: 00802526575303
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: P910077/S046
• 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,Followup
• Report Date (Section B): 11/03/2019

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
• Device Catalogue Number: 3120
• Device Lot Number: 057734
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/28/2019
• Initial Date Received by Manufacturer: 03/19/2019
• Supplement Date Received by Manufacturer: 09/19/2019
• Initial Report FDA Received Date: 05/06/2019
• Supplement Report FDA Received Date: 11/03/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1