MAUDE Adverse Event Report: UNKNOWN DRUG ELUTING PERMANENT LEFT VENTRICULAR (LV) PACEMAKER ELECTRODE

Model Number UNKNOWN

Device Problems Difficult to Remove (1528); Improper or Incorrect Procedure or Method (2017); Physical Resistance/Sticking (4012)

Patient Problem Insufficient Information (4580)

Event Type  malfunction  

Event Description

The grand slam guidewire (straight, 180 cm) was stuck in the 4958 attain performa s mri lead and could not be removed.Therefore, the lead had to be replaced with a new one.According to feedback of the hcp, they forgot to activate the hydrophobic coating of the guidewire before introducing it into the lead, what could have lead to this issue.Unfortunately, the hcp enforced the replacement of the guidewire after replacing the lead.He pulled with full power what damaged both guidewire and lead.(b)(4).This report reflects information received by fda in the form of a notification per 803.22 (b)(2).

• Brand Name: DRUG ELUTING PERMANENT LEFT VENTRICULAR (LV) PACEMAKER ELECTRODE
• Type of Device: DRUG ELUTING PERMANENT LEFT VENTRICULAR (LV) PACEMAKER ELECTRODE
• Manufacturer (Section D): UNKNOWN
• MDR Report Key: 17523320
• MDR Text Key: 321379280
• Report Number: MW5130268
• Device Sequence Number: 1
• Product Code: OJX
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 11/02/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/12/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: No
• Device Model Number: UNKNOWN
• Patient Sequence Number: 1