MAUDE Adverse Event Report: MEDTRONIC, INC. DUAL CHAMBER PACEMAKER; PULSE-GENERATOR, PACEMAKER, EXTERNAL

Model Number 5392

Device Problem Therapeutic or Diagnostic Output Failure (3023)

Patient Problems Cardiac Arrest (1762); Hypoxia (1918); Pneumonia (2011); Sepsis (2067); Respiratory Failure (2484); Heart Block (4444); Drug Resistant Bacterial Infection (4553)

Event Date 10/07/2022

Event Type  Injury  

Event Description

Patient post transvenous pacemaker placed on (b)(6) 2022.It was determined that the patient's medtronic temporary pacemaker malfunctioned on (b)(6) 2022 at 0700.At 0710 patient went into pulseless v-tach.A code blue was immediately initiated.Patient was defibrillated x1.Rosc(return of spontaneous circulation) achieved.Physician was at the bedside and the cardiologist was made aware.Orders obtained to have this patient transferred to another facility for complex cardiac needs.Pt with history of cardiogenic shock coronary artery disease non-st elevation mi(myocardial infraction) complex pci(percutaneous coronary intervention) with des(drug eluting test) x 4; impella has been removed vt(ventricular tachycardia).Cardioverted complete heart block.Tvp(temporary trans-venous pacing) acute respiratory failure with hypoxemia sepsis secondary to pneumonia -bronc culture with mssa(methicillin-sensitive staphylococcus aureus) staph epidermidis bacteremia -blood cultures x2 positive, shock liver anemia: with acute blood loss, normocytic acute kidney injury.Crrt(continuous renal replacement therapy) hyperkalemia.Fda safety report id # (b)(4).

• Brand Name: DUAL CHAMBER PACEMAKER
• Type of Device: PULSE-GENERATOR, PACEMAKER, EXTERNAL
• Manufacturer (Section D): MEDTRONIC, INC.
• MDR Report Key: 15658966
• MDR Text Key: 302350517
• Report Number: MW5112795
• Device Sequence Number: 1
• Product Code: DTE
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Risk Manager
• Type of Report: Initial
• Report Date: 10/19/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/21/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 5392
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Life Threatening; Other; Required Intervention
• Patient Age: 71 YR
• Patient Sex: Male
• Patient Weight: 110 KG
• Patient Ethnicity: Non Hispanic
• Patient Race: White