MAUDE Adverse Event Report: MPRI CAPSUREFIX LEAD; PERMANENT PACEMAKER ELECTRODE

Model Number 5568-53

Device Problems High impedance (1291); Connection Problem (2900); Impedance Problem (2950); High Capture Threshold (3266)

Patient Problems Dyspnea (1816); Fatigue (1849); Dizziness (2194); Anxiety (2328); No Clinical Signs, Symptoms or Conditions (4582)

Event Date 05/21/2023

Event Type  Injury  

Event Description

It was reported that the right atrial (ra) lead exhibited high and undefined impedance in addition to high thresholds.It was noted that there is a possible header/connection issue with the cardiac resynchronization therapy defibrillator (crt-d).The ra lead and crt-d remain in use. no patient complications have been reported as a result of this event.

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 atrial pacing lead was beyond the expected upper range.Analysis of the device memory indicated atrial pacing capture threshold was elevated.Continuation of d10: dtpa2d1 crt-d, 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.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.

Manufacturer Narrative

Correction: h6: device codes (fdd/annex a: a12).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

It was later reported by the patient that they were not feeling right within one week of implant of the new crt-d.The patient was feeling lightheaded, dizzy, and became fatigued fairly easily.The patient had never experienced the symptoms before.Everything checked out fine prior to the implant of the new crt-d.The patient could previously walk up multiple flights of stairs but was now tired and out of breath after one flight.The patient was afraid to go on walks for fear of passing out.The patient reported that at a post-operative check, it was found that the lead was disconnected or was not making contact with the crt-d and impedance measurements were changing.The patient's physician reportedly did not appear concerned about the disconnected lead and instead opted to change the patient's heart failure medication.The patient's symptoms have not changed since.They still get fatigued, dizzy, and lightheaded even with normal activity like getting up from the couch.The patient's physician had spoken to them about pacemaker syndrome with which the patient felt their symptoms aligned.The patient's main concern was a defect with the crt-d or lead.No further patient complications have been reported as a result of this event.

• Brand Name: CAPSUREFIX LEAD
• Type of Device: PERMANENT PACEMAKER ELECTRODE
• 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: 17140660
• MDR Text Key: 317335058
• Report Number: 2649622-2023-15419
• Device Sequence Number: 1
• Product Code: DTB
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: P930039
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Company Representative
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date: 02/21/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/15/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Expiration Date: 09/12/2008
• Device Model Number: 5568-53
• Device Catalogue Number: 5568-53
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 01/31/2024
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 10/12/2006
• 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: 694765 LEAD, 419388 LEAD
• Patient Outcome(s): Required Intervention
• Patient Age: 64 YR
• Patient Sex: Male