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

Model Number 6935M62

Device Problem Material Integrity Problem (2978)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 04/10/2024

Event Type  malfunction  

Event Description

It was reported that during a generator replacement, while tunneling the chronic leads from the patient's left side to their right side, the physician loosely tied a suture around the pin connector of the right ventricular (rv) lead.After the tunneling was completed, it was noted that the most distal metal ring on the connector pin had become separated/misaligned from the white plastic section adjacent to it.The physician positioned the ring back into place and it appeared normal.Subsequent impedance, sensing, and threshold testing showed that the lead performed well, and measurements were identical to those taken pre-tunnelling. defibrillation threshold (dft) testing also revealed no issues.It was further noted that the distal ring adjacent to the separated area is for the superior vena cava (svc), and this specific lead design does not have a svc coil.The decision was made to reuse the rv lead.The lead remains in use. no patient complications have been reported as a result of this event.

Manufacturer Narrative

Medtronic submits this report to comply with fda regulations 21 cfr parts 4 and 803.Medtronic has made reasonable efforts to provide 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.Any required fields that are unpopulated are blank because the information is currently unknown or unavailable.Medtronic will submit a supplemental report if additional relevant information becomes known.

• 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: 19206690
• MDR Text Key: 341422020
• Report Number: 2649622-2024-11840
• Device Sequence Number: 1
• Product Code: LWS
• UDI-Device Identifier: 00643169356566
• UDI-Public: 00643169356566
• 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: Other Health Care Professional
• Type of Report: Initial
• Report Date: 04/29/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/29/2024
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Expiration Date: 03/15/2019
• Device Model Number: 6935M62
• Device Catalogue Number: 6935M62
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 04/10/2024
• Date Device Manufactured: 04/20/2017
• 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: DTMB1QQ CDRTD, 459888 LEAD, 507652 LEAD
• Patient Age: 62 YR
• Patient Sex: Female
• Patient Weight: 99 KG