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

Model Number 694765

Device Problems Signal Artifact/Noise (1036); Failure to Capture (1081); Fracture (1260); High impedance (1291); Over-Sensing (1438)

Patient Problems Dyspnea (1816); Heart Failure (2206)

Event Date 07/04/2020

Event Type  Injury  

Manufacturer Narrative

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

Event Description

It was reported that the patient presented to the emergency department with shortness of breath and an alerting implantable cardioverter defibrillator (icd).An interrogation showed that the right ventricular (rv) lead triggered a lead integrity alert (lia) for non-sustained high rate episodes and sensing integrity counters (sic).In addition, noise was noted, the lead had no capture both bipolar and tip to coil and the pacing impedance was high and undefined.A lead fracture was suspected.The patient was admitted for exacerbation of heart failure and the defibrillation therapies on the lead were turned off.The lead remains in use; however, a lead revision is planned.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: 10320862
• MDR Text Key: 200248265
• Report Number: 2649622-2020-14224
• Device Sequence Number: 1
• Product Code: LWS
• UDI-Device Identifier: 00613994249890
• UDI-Public: 00613994249890
• 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
• Report Date: 07/24/2020

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
• Device Operator: Lay User/Patient
• Device Expiration Date: 05/06/2011
• Device Model Number: 694765
• Device Catalogue Number: 694765
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 07/04/2020
• Initial Date FDA Received: 07/24/2020
• Date Device Manufactured: 05/20/2009
• 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: DDBB1D1 ICD, 5076-52 LEAD
• Patient Outcome(s): Hospitalization; Required Intervention
• Patient Age: 49 YR
• Patient Weight: 117