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

Model Number	363724
Medical Device Problem Codes	Fracture (1260); Difficult to Advance (2920)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/19/2022
Type of Reportable Event	Malfunction
Event or Problem Description
During surgery the guidewire got stuck in the lead.By pulling firmly, the guidewire broke off and a piece remained in the lead.A new lead was provided.
Additional Manufacturer Narrative
Complaint investigation underway and will be attached to this report.
Event or Problem Description
During surgery the guidewire got stuck in the lead.By pulling firmly, the guidewire broke off and a piece remained in the lead.A new lead was provided.
Additional Manufacturer Narrative
Complaint investigation underway and will be 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; parkmore west business park; galway, H91 C K22; EI H91 CK22
• Manufacturer Contact: jaseem saqib ; parkmore west business park; galway, H91 C-K22 ; EI H91 CK22
• MDR Report Key: 15535155
• Report Number: 3006010712-2022-00043
• Device Sequence Number: 14773815
• Product Code: DQX
• UDI-Device Identifier: 04035479126285
• UDI-Public: 04035479126285
• 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: Administrator/Supervisor
• Remedial Action: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 11/03/2022

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 Expiration Date: 01/31/2026
• Device Model Number: 363724
• Device Catalogue Number: 363724 REV 16
• Device Lot Number: 6902196
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 09/19/2022
• Supplement Date Received by Manufacturer: 09/19/2022
• Initial Report FDA Received Date: 10/04/2022
• Supplement Report FDA Received Date: 11/04/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 02/25/2022
• 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