MAUDE Adverse Event Report: MEDTRONIC, INC. AMPLIA MRI QUAD CRT-D SURESCAN; DEFIBRILLATOR, AUTOMATIC IMPLANTABLE CARDIOVERTER (CRT-D)

Model Number DTMB1QQ

Device Problems Premature Discharge of Battery (1057); Therapeutic or Diagnostic Output Failure (3023)

Patient Problem Failure of Implant (1924)

Event Date 12/08/2020

Event Type  No Answer Provided  

Event Description

Patient's implantable cardioverter defibrillator generator noted to suddenly lose output.Device was interrogated and was unable to be communicated.Emergent generator change procedure was performed while inpatient and device was returned to manufacturer who was able to confirm device performance malfunction consistent with current premature battery depletion advisory.

• Brand Name: AMPLIA MRI QUAD CRT-D SURESCAN
• Type of Device: DEFIBRILLATOR, AUTOMATIC IMPLANTABLE CARDIOVERTER (CRT-D)
• Manufacturer (Section D): MEDTRONIC, INC.; 710 medtronic pkwy; minneapolis MN 55432
• MDR Report Key: 11423226
• MDR Text Key: 234985790
• Report Number: 11423226
• Device Sequence Number: 1
• Product Code: NIK
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: User Facility
• Reporter Occupation: Risk Manager
• Type of Report: Initial
• Report Date: 03/03/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/05/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: No
• Device Operator: No Information
• Device Model Number: DTMB1QQ
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/08/2020
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 03/03/2021
• Event Location: Hospital
• Date Report to Manufacturer: 03/05/2021
• Type of Device Usage: Unknown
• Patient Sequence Number: 1