MAUDE Adverse Event Report: MPRI SPRINT QUATTRO MRI SURESCAN; DEFIBRILLATOR, AUTOMATIC IMPLANTABLE CARDIOVERTER

Model Number	6946M62
Medical Device Problem Codes	Signal Artifact/Noise (1036); Over-Sensing (1438); Inappropriate/Inadequate Shock/Stimulation (1574)
Health Effect - Clinical Code	Shock from Patient Lead(s) (3162)
Date of Event	05/27/2020
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 inappropriately shocked by the right ventricular (rv) lead for oversensing of noise, artifacts, and t-wave.A follow up with the patient¿s healthcare provider yielded that the patient was seen and the lead was assess.The lead continues to be monitored and remains in use.No further patient complications have been reported as a result of this event.

• Brand Name: SPRINT QUATTRO MRI SURESCAN
• Common Device Name: DEFIBRILLATOR, AUTOMATIC IMPLANTABLE CARDIOVERTER
• Manufacturer (Section D): MPRI; road 149 km 56.3; villalba PR 00766
• MDR Report Key: 10166285
• Report Number: 2649622-2020-11513
• Device Sequence Number: 16584844
• Product Code: LWS
• UDI-Device Identifier: 00643169335578
• UDI-Public: 00643169335578
• Combination Product (Y/N): N
• Initial Reporter State: FL
• Initial Reporter Country: US
• PMA/510(K) Number: P920015
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2017
• Reporter Type: Manufacturer
• Report Source: health professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 06/18/2020

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: 08/23/2018
• Device Model Number: 6946M62
• Device Catalogue Number: 6946M62
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/27/2020
• Initial Report FDA Received Date: 06/18/2020
• 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: DVFB1D4 ICD
• Outcome Attributed to Adverse Event: Hospitalization; Life Threatening
• Patient Age: 32 YR