MAUDE Adverse Event Report: MPRI SPRINT FIDELIS; IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (NON-CRT)

Model Number 6949

Device Problems Fracture (1260); High impedance (1291); Defective Device (2588); Protective Measures Problem (3015)

Patient Problem Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available (4581)

Event Type  Injury  

Manufacturer Narrative

The initial reported event of high impedance, lead integrity alert and lead fractured were previously submitted via a remedial action exemption (rae) summary report.The manufacturer has voluntarily discontinued this rae, so supplemental information is being submitted via a 30 day report.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.Any required fields that are unpopulated are blank because the information is currently unknown or unavailable.A good faith effort will be made to obtain the applicable information relevant to the report.If information is provided in the future, a supplemental report will be issued.

Event Description

Lawsuit alleges, "plaintiff has sustained and will continue to sustain severe physical injuries and/or death, severe emotional distress, and economic and consequential damages." it was also reported that there was high impedance, the lead integrity alert triggered and the lead was fractured.The lead was capped and replaced due to medical judgement/system upgrade and a potential performance issue.The device was also explanted and replaced due to medical judgement/system upgrade and a potential performance issue.No patient complications have been reported as a result of this event.It was further reported that the lead was explanted and replaced.

• Brand Name: SPRINT FIDELIS
• 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: 17862809
• MDR Text Key: 324826216
• Report Number: 2649622-2023-26925
• Device Sequence Number: 1
• Product Code: LWS
• 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
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 10/03/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/03/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Expiration Date: 05/08/2008
• Device Model Number: 6949
• Device Catalogue Number: 6949
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 09/12/2023
• Date Device Manufactured: 05/16/2006
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: 7232CX ICD.
• Patient Outcome(s): Required Intervention; Hospitalization
• Patient Age: 36 YR
• Patient Sex: Female
• Patient Weight: 62 KG