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 Code	Electromagnetic Interference (1194)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	05/04/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Concomitant medical products: 4592 lead, implanted: (b)(6) 2011; 5076-52 lead, implanted: (b)(6)2011.If information is provided in the future, a supplemental report will be issued.
Event or Problem Description
It was reported that ventricular oversensing and noise were observed during a surgical procedure.It was suspected that this was due to the cardiac resynchronization therapy defibrillator (crt-d) exhibiting electromagnetic interference (emi) oversensing during the procedure.The crt-d remains in use.No patient complications have been reported as a result of this event.

• 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: 10071095
• Report Number: 3004209178-2020-08809
• Device Sequence Number: 678404
• Product Code: NIK
• UDI-Device Identifier: 00613994677853
• UDI-Public: 00613994677853
• Combination Product (Y/N): N
• Initial Reporter State: NC
• 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: health professional
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 05/19/2020

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 Expiration Date: 10/14/2016
• Device Model Number: D334TRG
• Device Catalogue Number: D334TRG
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/04/2020
• Initial Report FDA Received Date: 05/19/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: 6945-65 LEAD
• Patient Age: 67 YR
• Patient Weight: 57