MAUDE Adverse Event Report: MEDTRONIC EUROPE SARL PROTECTA XT DR; DEFIBRILLATOR, AUTOMATIC IMPLANTABLE CARDIOVERTER

Model Number	D314DRG
Medical Device Problem Codes	Over-Sensing (1438); Inappropriate/Inadequate Shock/Stimulation (1574); Invalid Sensing (2293)
Health Effect - Clinical Code	Shock from Patient Lead(s) (3162)
Date of Event	03/05/2018
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 while the patient was exercising the patient's implantable cardioverter defibrillator (icd) encountered a detection issue and t-wave oversensing (twos) problem.The right ventricular (rv) lead was also t-wave oversensing (twos) which lead to the patient receiving inappropriate therapy.Additionally, it was noted that there was electromagnetic interference (emi) on the right atrial (ra) lead egm of one of the recorded episodes.As the patient was exercising/swimming during this event, it is thought an improperly grounded pool may have caused/contributed to the emi.Reprogramming was completed and the device and leads remain in use.No further patient complications have been reported as a result of this event.

• Brand Name: PROTECTA XT DR
• Common Device Name: DEFIBRILLATOR, AUTOMATIC IMPLANTABLE CARDIOVERTER
• Manufacturer (Section D): MEDTRONIC EUROPE SARL; route du molliau 31; case postale; tolochenaz vaud 1131 ; CH 1131
• MDR Report Key: 7462062
• Report Number: 9614453-2018-01670
• Device Sequence Number: 19090224
• Product Code: LWS
• UDI-Device Identifier: 00613994678188
• UDI-Public: 00613994678188
• Combination Product (Y/N): N
• Initial Reporter State: NY
• Initial Reporter Country: US
• PMA/510(K) Number: P980016
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2011
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 04/25/2018

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: 04/14/2012
• Device Model Number: D314DRG
• Device Catalogue Number: D314DRG
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/05/2018
• Initial Report FDA Received Date: 04/25/2018
• 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: Hospitalization; Life Threatening; Required Intervention
• Patient Age: 80 YR
• Patient Weight: 94