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

Model Number	6944-58
Medical Device Problem Codes	Signal Artifact/Noise (1036); Fracture (1260); High impedance (1291); Connection Problem (2900); Impedance Problem (2950)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/23/2024
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that the right ventricular (rv) lead exhibited high out of range (oor) defibrillation impedances of the rv coil along with impedance spikes.The lead remains in use.No patient complications have been reported as a result of this event.
Additional Manufacturer Narrative
Continuation of d10: 419678 lead implanted on (b)(6) 2010, dtmb1d1 crtd implanted on (b)(6) 2023.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.
Additional 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.
Event or Problem Description
It was further reported that the superior vena cava (svc) coil of the right ventricular (rv) lead exhibited high out of range (oor) defibrillation impedances.A chest x-ray confirmed that the rv coil pin was not fully seated in the header.During a revision procedure the header was inspected and the pin appeared to be fully seated, and a tug test was completed during which none of the leads were noted to be loose.The rv lead was disconnected and tested with an analyzer which showed no evidence of noise and impedance and threshold measurements were stable.The rv lead was reconnected and the subsequent impedance values were noted to be lower and stable.The pocket was closed.Two days later an alert was triggered for oor high svc impedance, varying svc impedance was also noted, and non physiologic noise was observed on electrograms (egm).Fracture of the svc coil was suspected.The svc coil was programmed off and the clinician will continue to monitor the rv coil.The cardiac resynchronization therapy defibrillator (crt-d) remains in use.
Additional Manufacturer Narrative
Correction: b5 (corrected to indicated suspected rv coil fracture rather than svc).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.
Event or Problem Description
It was further reported that during a revision procedure the header was inspected and the pin appeared to be fully seated, and a tug test was completed during which none of the leads were noted to be loose.The right ventricular (rv) lead was disconnected and tested with an analyzer which showed no evidence of noise and impedance and threshold measurements were stable.The rv lead was reconnected and the subsequent impedance values were noted to be lower and stable.The pocket was closed.Two days later an alert was triggered for out of range (oor) high superior vena cava (svc) impedance, varying svc impedance was also noted, and non physiologic noise was observed on electrograms (egm).Fracture of the rv coil was suspected.The svc coil was programmed off and the clinician will continue to monitor the rv coil.
Additional 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.
Event or Problem Description
It was further reported that the rv lead was explanted and replaced.
Additional Manufacturer Narrative
Product event summary: the lead was not returned for analysis, however, performance data collected from the device was received and analyzed.Analysis of the device memory indicated the impedance of the right ventricular defibrillation coil was beyond the expected upper range.Analysis of the device memory indicated the impedance trend of the right ventricular defibrillation coil was variable.Analysis of the device memory indicated the impedance of the right ventricular defibrillation coil had a spike.Analysis of the device memory indicated the impedance of the superior vena cava defibrillation coil was beyond the expected upper range.Analysis of the device memory indicated the impedance trend of the superior vena cava defibrillation coil was variable.Analysis of the device memory indicated noise.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 LEAD
• Common Device Name: 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: gerard torenvliet ; 8200 coral sea st ne; mounds view, MN 55112-4391 ; 7635269277
• MDR Report Key: 19820108
• Report Number: 2649622-2024-19579
• Device Sequence Number: 8612671
• Product Code: LWS
• UDI-Device Identifier: 00613994249951
• UDI-Public: 00613994249951
• Combination Product (Y/N): N
• Initial Reporter State: PA
• Initial Reporter Country: US
• PMA/510(K) Number: P920015
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2010
• Device Explanted Year: 2024
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup,Followup,Followup
• Report Date (Section B): 01/29/2025

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
• Operator of Device: Lay User/Patient
• Device Expiration Date: 04/13/2012
• Device Model Number: 6944-58
• Device Catalogue Number: 6944-58
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/23/2024
• Supplement Date Received by Manufacturer: Not provided; 08/28/2024; 12/19/2024; 01/14/2025
• Initial Report FDA Received Date: 07/24/2024
• Supplement Report FDA Received Date: 08/18/2024; 08/28/2024; 01/07/2025; 01/29/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 04/21/2010
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: 407658 LEAD, 407652 LEAD.
• Outcome Attributed to Adverse Event: Required Intervention; Hospitalization
• Patient Age: 79 YR
• Patient Sex: Male