MAUDE Adverse Event Report: MEDTRONIC PUERTO RICO OPERATIONS CO. PROTECTA CRT-D; DEFIBRILLATOR, AUTOMATIC IMPLANTABLE CARDIOVERTER, WITH CARDIAC RESYNCHRONIZATIO

Model Number	D334TRG
Medical Device Problem Codes	Inappropriate/Inadequate Shock/Stimulation (1574); Invalid Sensing (2293); Device Sensing Problem (2917)
Health Effect - Clinical Code	Shock from Patient Lead(s) (3162)
Date of Event	01/22/2018
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
If information is provided in the future, a supplemental report will be issued.
Event or Problem Description
It was reported that the patient was in atrial fibrillation with rapid ventricular response and received an inappropriate shock for ventricular tachycardia after anti-tachycardia pacing.Reprogramming was done and the device remains in use.No further patient complications have been reported as a result of this event.
Additional Manufacturer Narrative
If information is provided in the future, a supplemental report will be issued.

• Brand Name: PROTECTA CRT-D
• Common Device Name: DEFIBRILLATOR, AUTOMATIC IMPLANTABLE CARDIOVERTER, WITH CARDIAC RESYNCHRONIZATIO
• Manufacturer (Section D): MEDTRONIC PUERTO RICO OPERATIONS CO.; road 31, km. 24, hm 4; ceiba norte industrial park; juncos PR 00777
• MDR Report Key: 7418459
• Report Number: 3004209178-2018-07592
• Device Sequence Number: 1575352
• Product Code: NIK
• UDI-Device Identifier: 00613994677853
• UDI-Public: 00613994677853
• Combination Product (Y/N): N
• Initial Reporter State: MI
• Initial Reporter Country: US
• PMA/510(K) Number: P010031
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2015
• Reporter Type: Manufacturer
• Report Source: company representative,consum
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 07/22/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Lay User/Patient
• Device Expiration Date: 10/14/2016
• Device Model Number: D334TRG
• Device Catalogue Number: D334TRG
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 01/22/2018
• Supplement Date Received by Manufacturer: 07/22/2019
• Initial Report FDA Received Date: 04/10/2018
• Supplement Report FDA Received Date: 07/22/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Life Threatening; Required Intervention
• Patient Age: 75 YR