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

Model Number 5076-52

Device Problems Signal Artifact/Noise (1036); Fracture (1260); High impedance (1291); Over-Sensing (1438); Pacing Problem (1439); Connection Problem (2900); High Capture Threshold (3266); Unstable Capture Threshold (3269)

Patient Problems Bradycardia (1751); Non specific EKG/ECG Changes (1817)

Event Date 08/25/2022

Event Type  Injury  

Manufacturer Narrative

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 reported that the right ventricular (rv) lead has a fracture.It was noted that the rv lead had oversensing of noise resulting in long pauses of up to sixteen seconds on the external cardiac monitor and an escape rhythm of a dropped heart rate to low beats per minute range for a prolonged period of time.It was also noted that the oversensing could be causing inhibition of pacing.This resulted in the patient staying in the intensive care unit (icu) and transported to another facility.It was further reported that the patient felt like they were going to pass out.Unstable threshold measurements and elevated and undefined impedance measurements was noted on the rv lead.A polarity switch was also observed due to the lead issues.It was also noted that the left ventricular (lv) lead had an increase in threshold measurements.The lv lead remains in use and the lead rv lead was capped and replaced.During the lead revision procedure, the physician attempted to reuse the cardiac resynchronization therapy pacemaker (crt-p), however the setscrew would not engage the wrench.It was noted that the wrench could not fasten down the setscrew to the lead.Multipl e wrenches were used with no success.The device was explanted and replaced.No further 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 oversensing associated with the right ventricular lead.Analysis of the device memory indicated the impedance of the right ventricular pacing lead was beyond the expected upper range.Analysis of the device memory indicated pacing capture threshold in the right ventricle was unstable.Analysis of the device memory indicated a polarity switch.Analysis of the device memory indicated oversensing due to non-physiologic signals/sensing integrity counter.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

Additional information received indicated it was observed during regular follow up that the rv lead threshold increased.The lv lead had no issues.During the rv lead revision procedure, when the crt-p device was removed from the pocket it was found that the rv lead was not secured down with the set screw.The crt-p device set screw appeared to be missing which is most likely why the rv lead was showing high impedance and high threshold.Because the set screw was missing, a new crt-p was needed.The original rv lead was tested via the analyzer and its testing was normal.It was physician preference to keep the new rv lead implanted just in case.

• Brand Name: CAPSUREFIX NOVUS LEAD MRI SURESCAN
• 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: 15421954
• MDR Text Key: 299901016
• Report Number: 2649622-2022-18351
• Device Sequence Number: 1
• Product Code: DTB
• UDI-Device Identifier: 00643169633759
• UDI-Public: 00643169633759
• 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: Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 09/28/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/14/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Expiration Date: 08/16/2021
• Device Model Number: 5076-52
• Device Catalogue Number: 5076-52
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 09/15/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 09/08/2019
• 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: W4TR01 CRTP, 459888 LEAD
• Patient Outcome(s): Hospitalization; Required Intervention
• Patient Age: 89 YR
• Patient Sex: Female
• Patient Weight: 70 KG