MAUDE Adverse Event Report: MEDTRONIC, INC. MEDTRONIC CARELINK MONITOR (PATIENT HOME MONITOR); PULSE GENERATOR, PERMANENT, IMPLANTABLE

Model Number	2490C15
Medical Device Problem Code	Inappropriate/Inadequate Shock/Stimulation (1574)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/01/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
If information is provided in the future, a supplemental report will be issued.
Event or Problem Description
A clinician reported that the monitor shocked the patient.No troubleshooting indicated.The monitor was replaced.No patient complications have been reported as a result of this event.

• Brand Name: MEDTRONIC CARELINK MONITOR (PATIENT HOME MONITOR)
• Common Device Name: PULSE GENERATOR, PERMANENT, IMPLANTABLE
• Manufacturer (Section D): MEDTRONIC, INC.; 8200 coral sea street ne; mounds view MN 55112
• MDR Report Key: 10949772
• Report Number: 2182208-2020-03178
• Device Sequence Number: 3190100
• Product Code: NVZ
• UDI-Device Identifier: 00643169191815
• UDI-Public: 00643169191815
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: P890003
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: health professional
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 12/04/2020

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
• Operator of Device: Lay User/Patient
• Device Model Number: 2490C15
• Device Catalogue Number: 2490C15
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/01/2020
• Initial Report FDA Received Date: 12/04/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 73 YR