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

Model Number	694758
Medical Device Problem Code	High Capture Threshold (3266)
Health Effect - Clinical Code	Chest Pain (1776)
Date of Event	02/27/2018
Type of Reportable Event	Malfunction
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 presented to the ed (emergency department) with chest pain.An interrogation of there device was done and it was found that and alert for high rv threshold was triggered for the right ventricular (rv) lead.It was noted that the rv lead has chronically measured high for rv thresholds.The rv lead remains in use.No patient complications have been reported as a result of this event.

• Brand Name: SPRINT QUATTRO SECURE
• Common Device Name: DEFIBRILLATOR, AUTOMATIC IMPLANTABLE CARDIOVERTER
• Manufacturer (Section D): MPRI; road 149 km 56.3; villalba PR 00766
• MDR Report Key: 7415416
• Report Number: 2649622-2018-03930
• Device Sequence Number: 13769193
• Product Code: LWS
• UDI-Device Identifier: 00643169535961
• UDI-Public: 00643169535961
• Combination Product (Y/N): N
• Initial Reporter State: LA
• Initial Reporter Country: US
• PMA/510(K) Number: P920015
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2016
• Reporter Type: Manufacturer
• Report Source: health professional
• Initial Reporter Occupation: Health Professional
• Type of Report: Initial
• Report Date (Section B): 04/10/2018

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: 11/17/2017
• Device Model Number: 694758
• Device Catalogue Number: 694758
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/27/2018
• Initial Report FDA Received Date: 04/10/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 73 YR