MAUDE Adverse Event Report: BIOTRONIK SE & CO. KG LINOX T 65; ICD LEAD

Model Number 351353

Device Problems Fracture (1260); Inappropriate/Inadequate Shock/Stimulation (1574); Ambient Noise Problem (2877)

Patient Problem Shock from Patient Lead(s) (3162)

Event Date 03/27/2024

Event Type  Injury  

Event Description

There were 20 shock activations under consciousness due to improper activation.Check at hospital shows noise, possibly a fracture.Should additional information be received, this file will be updated.

• Brand Name: LINOX T 65
• Type of Device: ICD LEAD
• Manufacturer (Section D): BIOTRONIK SE & CO. KG; woermannkehre 1; berlin 12359 ; DE 12359
• Manufacturer Contact: 6024 jean road; lake oswego, OR 97035 ; 8772459800
• MDR Report Key: 19047328
• MDR Text Key: 339429688
• Report Number: 1028232-2024-01887
• Device Sequence Number: 1
• Product Code: NVY
• Combination Product (y/n): N
• Reporter Country Code: DE
• PMA/PMN Number: P980023
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Company Representative
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 04/04/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 07/31/2011
• Device Model Number: 351353
• Device Catalogue Number: SEE MODEL NO.
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 04/04/2024
• Date Device Manufactured: 07/03/2009
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization