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

Model Number 6935M55

Device Problem Positioning Problem (3009)

Patient Problems Dyspnea (1816); Heart Failure (2206); Complaint, Ill-Defined (2331)

Event Date 05/31/2019

Event Type  Injury  

Manufacturer Narrative

Concomitant medical products: dtma1qq icd; 459888 lead, implanted: (b)(6) 2018.If information is provided in the future, a supplemental report will be issued.

Event Description

It was reported that the right ventricular (rv) lead held the tricuspid valve open, causing problems for the patient.The lead was repositioned so that the valve was not held open due to the rv lead and the lead remains in use.No further patient complications have been reported as a result of this event.

Manufacturer Narrative

If information is provided in the future, a supplemental report will be issued.

Event Description

Additional information received noted the patient was experiencing right side heart failure causing shortness of breath and fluid buildup.

• Brand Name: SPRINT QUATTRO SECURE S 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: 8723168
• MDR Text Key: 148800345
• Report Number: 2649622-2019-10664
• Device Sequence Number: 1
• Product Code: LWS
• UDI-Device Identifier: 00643169356559
• UDI-Public: 00643169356559
• 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: company representative,health
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 06/24/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/21/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Expiration Date: 07/16/2020
• Device Model Number: 6935M55
• Device Catalogue Number: 6935M55
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 06/21/2019
• Date Device Manufactured: 08/03/2018
• 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: 5076-45 LEAD
• Patient Outcome(s): Hospitalization; Required Intervention
• Patient Age: 76 YR