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

Model Number 6935M55

Device Problems Signal Artifact/Noise (1036); Positioning Failure (1158); Over-Sensing (1438); Inappropriate/Inadequate Shock/Stimulation (1574); Activation, Positioning or Separation Problem (2906); Device Dislodged or Dislocated (2923)

Patient Problems Shock from Patient Lead(s) (3162); Twiddlers Syndrome (4563)

Event Date 02/02/2023

Event Type  Injury  

Event Description

It was reported that the patient was admitted to the hospital after feeling like being punched when getting up.A check on the device yielded that the patient had twiddled the left ventricular (lv) lead and the right ventricular (rv) lead, dislodging both the lv and rv leads.The patient was inappropriately shocked by the rv lead for oversensing of noise.The right ventricular (rv) lead triggered a lead integrity alert (lia) for high rate non-sustained (hr-ns) and sensing integrity counter (sic) episodes.A chest x-ray showed that the lv lead pulled back into the superior vena cava (svc) and slack was removed from the rv lead.The lv lead was found to have increased high thresholds and no capture.The patient was brought emergently to the catheterization lab for lead revision.A temporary lead was placed and the rv lead was attempted to be repositioned but the lead helix would not retract or extend.The rv lead was removed and a new lead was implanted.The lv lead was attempted to be repositioned but was unsuccessful.The lv lead was removed and was not replaced.No further patient complications have been reported as a result of this event.

Manufacturer Narrative

Concomitant medical products: product id: 459888 lead, implanted: (b)(6) 2023.Medtronic is submitting this report to comply with fda reporting regulations under 21 cfr parts 4 and 803.This report is based upon information obtained by medtronic, which the company may not have been able to fully investigate or verify prior to the date the report was required by the fda.Medtronic has made reasonable efforts to obtain more complete information and has provided as much relevant information as is available to the company as of the submission date of this report.This report does not constitute an admission or a conclusion by fda, medtronic, or its employees that the device, medtronic, or its employee caused or contributed to the event described in the report.In particular, this report does not constitute an admission by anyone that the product described in this report has any ¿defects¿ or has ¿malfunctioned¿.These words are included in the fda 3500a form and are fixed items for selection created by the fda to categorize the type of event solely for the purpose of regulatory reporting.Medtronic objects to the use of these words and others like them because of the lack of definition and the connotations implied by these terms.This statement should be included with any information or report disclosed to the public under the freedom of information act.

• 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: 16387924
• MDR Text Key: 309745288
• Report Number: 2649622-2023-04174
• 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: Consumer,Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 02/16/2023

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: 05/03/2024
• Device Model Number: 6935M55
• Device Catalogue Number: 6935M55
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 02/03/2023
• Initial Date FDA Received: 02/16/2023
• Date Device Manufactured: 05/17/2022
• 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: DTPA2QQ ICD, 5867-3M LEAD ADAPTOR, 6725 PIN PLUG.
• Patient Outcome(s): Required Intervention; Hospitalization; Life Threatening
• Patient Age: 82 YR
• Patient Sex: Female
• Patient Weight: 80 KG