MAUDE Adverse Event Report: LAKE REGION MEDICAL STREAMER ES, STR, 195-014

Model Number	363724
Medical Device Problem Code	Separation Problem (4043)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/11/2024
Type of Reportable Event	Malfunction
Event or Problem Description
When placing and manipulating the lv lead using the wire, the blue coating detached and pushed together.Only with great force and using a clamp the wire could be pulled out of the lead.
Additional Manufacturer Narrative
Complaint investigation underway and will be attached to this report.
Event or Problem Description
When placing and manipulating the lv lead using the wire, the blue coating detached and pushed together.Only with great force and using a clamp the wire could be pulled out of the lead.
Additional Manufacturer Narrative
Complaint investigation form attached to this report.

• Brand Name: STREAMER ES, STR, 195-014
• Common Device Name: STREAMER ES, STR, 195-014
• Manufacturer (Section D): LAKE REGION MEDICAL; parkmore west business park,; galway, H91 C K22; EI H91 CK22
• Manufacturer (Section G): LAKE REGION MEDICAL; lake region medical; parkmore west business park; galway, H91 C K22; EI H91 CK22
• Manufacturer Contact: amy carter ; parkmore west business park; galway, ireland H91 C-K22 ; EI H91 CK22
• MDR Report Key: 20607782
• Report Number: 3006010712-2024-00048
• Device Sequence Number: 12627191
• Product Code: DQX
• UDI-Device Identifier: 04035479126285
• UDI-Public: (01)04035479126285(17)271231(10)8804505
• Combination Product (Y/N): N
• Initial Reporter Country: GM
• PMA/510(K) Number: K083094
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Distributor
• Initial Reporter Occupation: Non-Healthcare Professional
• Remedial Action: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 12/12/2024

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: Health Professional
• Device Model Number: 363724
• Device Catalogue Number: 363724 REV 16
• Device Lot Number: 8804505
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 10/21/2024
• Supplement Date Received by Manufacturer: 10/21/2024
• Initial Report FDA Received Date: 11/05/2024
• Supplement Report FDA Received Date: 12/12/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 02/21/2024
• 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 Sex: Unknown