MAUDE Adverse Event Report: PLEXUS LATITUDE PROGRAMMING SYSTEM; EXTERNAL PROGRAMMER

Model Number 3300

Device Problems No Display/Image (1183); Defective Device (2588); Application Program Problem (2880); Device Sensing Problem (2917); Interrogation Problem (4017)

Patient Problems No Consequences Or Impact To Patient (2199); No Clinical Signs, Symptoms or Conditions (4582)

Event Date 07/20/2020

Event Type  malfunction  

Manufacturer Narrative

The product has been received for analysis.Upon completion of the failure analysis of the complaint product, if there is any further relevant information from that review, a supplemental report will be filed.

Event Description

It was reported that this programmer froze up with error code.The health care professional (hcp) smelled something hot or burning.The hcp also noticed noise on the electrogram (egm) and when doing testing, there was no surface egm.Boston scientific technical services (ts) discussed temperature range issue and advised the field representative to repeat all testing with the device.Furthermore, the clinic informed the field representative that the programmer would not interrogate, would not load reports and part of the screen was greyed out.Additional information received from the field indicated that the issue towards the patient's device with a programmer was resolved.The field representative replaced the programmer and returning the old programmer back.No adverse patient effects were reported.

Manufacturer Narrative

Upon receipt at our post market quality assurance laboratory, a thorough evaluation of the programmer was performed.Detailed analysis did confirm the allegations made with the programmer.The programmer failed the functional test due to the presence of an error code.The error was narrowed down to ecg board where the y2 was oscillating at a low amplitude.The ecg board was replaced to resolve this issue.Moreover, there were no noisy signals noted during testing and the device passed testing.The cause traced to component failure conclusion code was based on analysis of the returned product which found evidence of a hardware failure on the ecg board.

Event Description

It was reported that this programmer froze up with error code.The health care professional (hcp) smelled something hot or burning.The hcp also noticed noise on the electrogram (egm) and when doing testing, there was no surface egm.Boston scientific technical services (ts) discussed temperature range issue and advised the field representative to repeat all testing with the device.Furthermore, the clinic informed the field representative that the programmer would not interrogate, would not load reports and part of the screen was greyed out.Additional information received from the field indicated that the issue towards the patient's device with a programmer was resolved.The field representative replaced the programmer and returning the old programmer back.No adverse patient effects were reported.

• Brand Name: LATITUDE PROGRAMMING SYSTEM
• Type of Device: EXTERNAL PROGRAMMER
• Manufacturer (Section D): PLEXUS; 2400 millbrook dr; buffalo grove IL 60089
• Manufacturer (Section G): PLEXUS ELECTRONICA S DE RL DE CV; paseo del norte no; 4640 guadalajara; zapopan, jal 45010 ; MX 45010
• Manufacturer Contact: timothy degroot ; 4100 hamline avenue north; saint paul, MN 55112 ; 6515826168
• MDR Report Key: 10767896
• MDR Text Key: 214113035
• Report Number: 2124215-2020-22538
• Device Sequence Number: 1
• Product Code: OSR
• UDI-Device Identifier: 00802526610202
• UDI-Public: 00802526610202
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: P910077/S159
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,Company Representative
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 05/10/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/01/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 3300
• Device Catalogue Number: 3300
• Device Lot Number: 011770
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/15/2020
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 03/14/2022
• Was Device Evaluated by Manufacturer?: Yes
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1
• Patient Age: 50 YR
• Patient Sex: Female