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

Model Number 6935M62

Device Problems Fracture (1260); High impedance (1291); Over-Sensing (1438); Impedance Problem (2950); Material Deformation (2976)

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

Event Date 10/25/2021

Event Type  Injury  

Event Description

It was reported that the right ventricular (rv) lead fractured and exhibited an acute rise to high pacing impedance and was oversensing.During the extraction procedure it was noted that the rv lead conductor broke at the proximal 15cm lead part, and that when placing an extraction sheath over the lead mid-way the conductor was ¿bunching up¿ before the sheath.The lead was explanted and replaced.No patient complications have been reported as a result of this event.

Manufacturer Narrative

Product event summary: the distal portion of the lead was returned, analyzed.Analysis indicated the distal conductor of the lead developed a fracture due to flexing while in vivo.If information is provided in the future, a supplemental report will be issued.

• 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: 12824073
• MDR Text Key: 280877051
• Report Number: 2649622-2021-22856
• 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: Physician
• Type of Report: Initial
• Report Date: 11/16/2021

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: 06/08/2019
• Device Model Number: 6935M62
• Device Catalogue Number: 6935M62
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/08/2021
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 10/25/2021
• Initial Date FDA Received: 11/16/2021
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 06/28/2017
• 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: 407652 LEAD, DDMC3D4 ICD
• Patient Outcome(s): Hospitalization; Required Intervention
• Patient Age: 58 YR
• Patient Sex: Female
• Patient Weight: 69 KG