MAUDE Adverse Event Report: JABIL CIRCUIT (SHANGHAI) LTD LATITUDE Communicator; Pacemaker/Icd/Crt Non-Implanted Components

Model Number	6290
Medical Device Problem Codes	Application Program Problem (2880); Communication or Transmission Problem (2896)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/03/2026
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
If pertinent information is provided in the future, a supplemental report will be submitted.The product was not returned for analysis; therefore, a technical analysis could not be performed.Based on a thorough review of the reported complaint, boston scientific has assigned an investigation conclusion code of cause not established.
Event or Problem Description
It was reported that the implanted device recorded two ventricular episodes with tachy therapy from (b)(6), however, the communicator alerts were not detected by the consult report uploaded on may 6.It was noted that these stored episodes were of interest because of a recent hospitalization due to heart attack.Review of transmission data indicated the communicator alerts were not posted until may 21, due to cellular connection issues.This communicator remains in service.No adverse patient effects were reported.

• Brand Name: LATITUDE Communicator
• Common Device Name: Pacemaker/Icd/Crt Non-Implanted Components
• Manufacturer (Section D): JABIL CIRCUIT (SHANGHAI) LTD; 600 tian lin rd; shanghai ; CH
• Manufacturer (Section G): JABIL CIRCUIT SHANGHAI LTD; 600 tian lin rd; shanghai, 020 20023 3; CH 200233
• Manufacturer Contact: mark mischke ; 4100 hamline avenue north; saint paul, MN 55112 ; +1(612)875-7234
• MDR Report Key: 25562167
• Report Number: 2124215-2026-32796
• Device Sequence Number: 9995436
• Product Code: OSR
• UDI-Device Identifier: 00802526585609
• UDI-Public: (01)00802526585609
• Combination Product (Y/N): N
• Initial Reporter State: MA
• Initial Reporter Country: US
• PMA/510(K) Number: P910077/S140
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Consumer,Health Professional,Company Representative
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup,Followup,Followup
• Report Date (Section B): 09/10/2026

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: Lay User/Patient
• Device Model Number: 6290
• Device Catalogue Number: 6290
• Device Lot Number: 5352792
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/26/2026
• Supplement Date Received by Manufacturer: 06/18/2026; 07/23/2026; 09/10/2026
• Initial Report FDA Received Date: 06/19/2026
• Supplement Report FDA Received Date: 07/14/2026; 07/31/2026; 09/10/2026
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Age: 53 YR
• Patient Sex: Male