MAUDE Adverse Event Report: BENCHMARK ZOOM LATITUDE; EXTERNAL PROGRAMMER

Model Number 3120

Device Problems Defective Device (2588); Device Displays Incorrect Message (2591); Material Integrity Problem (2978)

Patient Problem No Patient Involvement (2645)

Event Date 08/24/2020

Event Type  malfunction  

Manufacturer Narrative

This product has not been returned for analysis.This report will be updated should additional information become available or if analysis is completed.

Event Description

It was reported that this programmer exhibited frozen screen and displayed error codes.Troubleshooting was done but unsuccessful.In addition, the programmer emitted slight smell of burning electronics.The programmer will be returned.No patient involvement was reported.

• Brand Name: ZOOM LATITUDE
• Type of Device: EXTERNAL PROGRAMMER
• Manufacturer (Section D): BENCHMARK; 4065 theurer boulevard; winona MN 55987
• Manufacturer (Section G): BOSTON SCIENTIFIC CORPORATION
• Manufacturer Contact: timothy degroot ; 4100 hamline avenue north; saint paul, MN 55112 ; 6515826168
• MDR Report Key: 10714373
• MDR Text Key: 212376552
• Report Number: 2124215-2020-21008
• Device Sequence Number: 1
• Product Code: LWS
• UDI-Device Identifier: 00802526564703
• UDI-Public: 00802526564703
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: P910077/S046
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 10/21/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/21/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Model Number: 3120
• Device Catalogue Number: 3120
• Device Lot Number: 058733
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 08/24/2020
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 11/22/2005
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1