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

Model Number 6946M55

Device Problems Failure to Capture (1081); High impedance (1291); Impedance Problem (2950); High Capture Threshold (3266); Unstable Capture Threshold (3269)

Patient Problems Muscle Stimulation (1412); Cardiac Perforation (2513)

Event Date 10/08/2020

Event Type  Injury  

Manufacturer Narrative

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

Event Description

It was reported that just over a week after implant diaphragmatic stimulation was noted and a right ventricular (rv) lead perforation was suspected.The lead had high and unstable pacing thresholds with no capture at maximum output on tip to ring as well as high undefined and variable pacing impedance, the lead was explanted and replaced.No further patient complications have been reported as a result of this event.

• Brand Name: SPRINT QUATTRO 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: 10708774
• MDR Text Key: 212250137
• Report Number: 2649622-2020-20273
• Device Sequence Number: 1
• Product Code: LWS
• UDI-Device Identifier: 00643169858305
• UDI-Public: 00643169858305
• 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: 10/20/2020

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: 01/28/2022
• Device Model Number: 6946M55
• Device Catalogue Number: 6946M55
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 10/08/2020
• Initial Date FDA Received: 10/20/2020
• Date Device Manufactured: 04/14/2020
• 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
• Patient Outcome(s): Hospitalization; Life Threatening; Required Intervention
• Patient Age: 52 YR