MAUDE Adverse Event Report: ST JUDE MEDICAL DRUG ELUTING PERMANENT RIGHT VENTRICULAR (RV) OR RIGHT ATRIAL (RA) PACEMAKER ELE

Model Number 7120

Device Problems Device Displays Incorrect Message (2591); Communication or Transmission Problem (2896)

Patient Problem Insufficient Information (4580)

Event Date 10/02/2022

Event Type  Injury  

Event Description

Patient is admitted at the hospital (customer did not disclose reason for being in hospital) patient noted that his device was beeping occasionally since last night.Customer indicated they did a cle tx last night that reported an unsuccessful carelink alert transmission.(b)(6) 2022 18:00:05 *unsuccessful ca relink alert transmission.(b)(6) 2022 15:00:05 svc defib lead impedance 101 ohms.(b)(6).This report reflects information received by fda in the form of a notification per 803.22 (b)(2).

• Brand Name: DRUG ELUTING PERMANENT RIGHT VENTRICULAR (RV) OR RIGHT ATRIAL (RA) PACEMAKER ELE
• Type of Device: DRUG ELUTING PERMANENT RIGHT VENTRICULAR (RV) OR RIGHT ATRIAL (RA) PACEMAKER ELE
• Manufacturer (Section D): ST JUDE MEDICAL
• MDR Report Key: 17488614
• MDR Text Key: 320688374
• Report Number: MW5121313
• Device Sequence Number: 1
• Product Code: NVN
• 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: 08/01/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/09/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: No
• Device Model Number: 7120
• Patient Sequence Number: 1