MAUDE Adverse Event Report: MEDTRONIC, INC. LOOP RECORDER; DETECTOR AND ALARM, ARRHYTHMIA

Model Number 24960

Patient Problem Hemorrhage/Bleeding (1888)

Event Date 08/06/2023

Event Type  Injury  

Event Description

Medtronic loop recorder was implanted without my consent, devices hemorrhaged post discharge.I had to go to the nearest hospital from my home at (b)(6).I was treated and released.I received a text ¿pn¿ my phone from medtronic my device was not transponding to the cardiologist 24/7 monitoring office at (b)(6) dr.(b)(6) and the office had no idea my device wasn't transponding for over a month.I had to order a transponder from medtronic myself.This is patient care.

• Brand Name: LOOP RECORDER
• Type of Device: DETECTOR AND ALARM, ARRHYTHMIA
• Manufacturer (Section D): MEDTRONIC, INC.
• MDR Report Key: 19116728
• MDR Text Key: 340510534
• Report Number: MW5153882
• Device Sequence Number: 1
• Product Code: DSI
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Patient
• Type of Report: Initial
• Report Date: 04/11/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 24960
• Device Catalogue Number: MENB1020A0502C02
• Was Device Available for Evaluation?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 04/15/2024
• Patient Sequence Number: 1
• Patient Outcome(s): Other; Hospitalization
• Patient Age: 55 YR
• Patient Sex: Female
• Patient Weight: 2 KG
• Patient Ethnicity: Non Hispanic
• Patient Race: White