MAUDE Adverse Event Report: ST. JUDE MEDICAL PULSE GENERATOR, PERMANENT, IMPLANTABLE

Model Number 1888TC

Device Problems Device Dislodged or Dislocated (2923); High Capture Threshold (3266)

Patient Problem Insufficient Information (4580)

Event Date 06/21/2012

Event Type  malfunction  

Event Description

This ra lead was implanted on (b)(6) 2012.A call to technical services on 6/20/12 states that they couldn't find a decent threshold in the ra.Additional information received states that the atrial lead dislodged immediately post implant while in the hospital and was repositioned on (b)(6) 2012.Thresholds were ~1.5@ 0.5ms.When seen one week post implant in the clinic thresholds were more elevated (unsure of how high).Dr.(b)(6) states that the thresholds are excellent now and he called the initial rise due to new anti-arrhythmic medication and inflammation.This report reflects information received by fda in the form of a notification per 803.22 (b)(2).

• Brand Name: PULSE GENERATOR, PERMANENT, IMPLANTABLE
• Type of Device: PULSE GENERATOR, PERMANENT, IMPLANTABLE
• Manufacturer (Section D): ST. JUDE MEDICAL
• MDR Report Key: 17534947
• MDR Text Key: 321518216
• Report Number: MW5141847
• Device Sequence Number: 1
• Product Code: NVZ
• 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: 08/10/2012

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: 1888TC
• Patient Sequence Number: 1