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

Model Number 694758

Device Problem Failure to Capture (1081)

Patient Problems Bradycardia (1751); Weakness (2145); Dizziness (2194)

Event Date 05/08/2020

Event Type  malfunction  

Manufacturer Narrative

Concomitant medical products: ddbb1d1 icd implanted: (b)(6) 2018.If information is provided in the future, a supplemental report will be issued.

Event Description

It was reported that the patient experienced dizziness and weakness.It was determined the patient's heart rate was in the range of 40 beats per minute.Per the patient's transmission, pacing spikes were evident with no capture.The right ventricular (rv) lead remains in use.No further patient complications have been reported as a result of this event.

• Brand Name: SPRINT QUATTRO SECURE MRI SURESCAN
• Type of Device: DEFIBRILLATOR, AUTOMATIC IMPLANTABLE CARDIOVERTER
• Manufacturer (Section D): MPRI; road 149 km 56.3; villalba PR 00766
• Manufacturer (Section G): MPRI; road 149 km 56.3; villalba PR 00766
• Manufacturer Contact: paula bixby ; 8200 coral sea st ne; mounds view, MN 55112 ; 7635055378
• MDR Report Key: 10096304
• MDR Text Key: 192410682
• Report Number: 2649622-2020-10134
• Device Sequence Number: 1
• Product Code: LWS
• UDI-Device Identifier: 00613994249876
• UDI-Public: 00613994249876
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: P920015
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 05/28/2020

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
• Device Operator: Lay User/Patient
• Device Expiration Date: 01/12/2012
• Device Model Number: 694758
• Device Catalogue Number: 694758
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 05/08/2020
• Initial Date FDA Received: 05/28/2020
• Date Device Manufactured: 01/26/2010
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Treatment: 4470 LEAD
• Patient Age: 83 YR
• Patient Weight: 82