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

Model Number 4195

Device Problem Pacing Problem (1439)

Patient Problem Insufficient Information (4580)

Event Date 10/09/2012

Event Type  malfunction  

Event Description

Technical services received a call on (b)(6) 2012 from sales rep.The lead was implanted on (b)(6) 2012.(b)(6) md / (b)(6) clinic in (b)(6) the pacing threshold is 0.5v@0.4ms - i know he lowered the output from the acute setting of 3.5v (to what, i don't know).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): MEDTRONIC
• MDR Report Key: 17537356
• MDR Text Key: 321519839
• Report Number: MW5144235
• 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: 11/13/2012

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: 4195
• Patient Sequence Number: 1