MAUDE Adverse Event Report: MPRI SPRINT QUATTRO SECURE S MRI SURESCAN; IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (NON-CRT)

Model Number 6935M55

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Undesired Nerve Stimulation (1980); Device Overstimulation of Tissue (1991)

Event Date 09/06/2022

Event Type  Injury  

Manufacturer Narrative

Concomitant medical products: dtma1d4, implanted: (b)(6) 2021.If information is provided in the future, a supplemental report will be issued.

Event Description

It was reported that the patient experienced a history of intermittent phrenic nerve stimulation and diaphragmatic stimulation caused by the right ventricular (rv) lead.It was noted that the left ventricular (lv) lead had high and undefined impedance measurements and high threshold measurements of the right atrial (ra) lead was also noted.It was further reported that the physician was unable to recreate any stimulation from the ra lead or the rv lead.The lv lead was capped and replaced.Reprogramming was done to the rv lead and both the rv lead and ra lead remain in use.No further patient complications have been reported as a result of this event.

• Brand Name: SPRINT QUATTRO SECURE S MRI SURESCAN
• Type of Device: IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (NON-CRT)
• 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: 15522924
• MDR Text Key: 300995471
• Report Number: 2649622-2022-19698
• Device Sequence Number: 1
• Product Code: LWS
• UDI-Device Identifier: 00643169309760
• UDI-Public: 00643169309760
• 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,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 09/30/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/01/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Expiration Date: 05/08/2017
• Device Model Number: 6935M55
• Device Catalogue Number: 6935M55
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 09/06/2022
• Date Device Manufactured: 05/29/2015
• 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: 419388 LEAD, 5076-52 LEAD
• Patient Outcome(s): Required Intervention
• Patient Age: 75 YR
• Patient Sex: Female