MAUDE Adverse Event Report: MPRI ATTAIN PERFORMA MRI SURESCAN; DRUG ELUTING PERMANENT LEFT VENTRICULAR (LV) PACEMAKER ELECTRODE

Model Number 429888

Device Problems Signal Artifact/Noise (1036); Mechanical Problem (1384); Low impedance (2285); Impedance Problem (2950); High Capture Threshold (3266)

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

Event Date 06/21/2021

Event Type  malfunction  

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 left ventricular pacing lead was below the expected lower range, the trend was decreasing and pacing capture threshold was high.If information is provided in the future, a supplemental report will be issued.

Event Description

It was reported that the left ventricular (lv) lead exhibited high thresholds, a warning for low pacing impedance, and the lv lead impedance trend displayed multiple drops in impedance.It was also noted there were abnormal egm signals/artifacts.A lead integrity issue was suspected for possible insulation issue.Due to the changes in lv output, the cardiac resynchronization therapy pacemaker (crt-p) longevity suddenly decreased.The lv threshold and impedance temporarily stabilized resulting in an increase and recovery in device longevity.The crt-p and lv lead remain in use.No patient complications have been reported as a result of this event.

Event Description

It was reported that the left ventricular (lv) lead exhibited high thresholds, a warning for low pacing impedance, and the lv lead i mpedance trend displayed multiple drops in impedance.It was also noted there were abnormal egm signals/artifacts.A lead integrity issue was suspected for possible insulation issue.It was noted that the patient was using a power tool on that day.The lv lead remains in use.It was also reported that the cardiac resynchronization therapy pacemaker (crt-p) longevity suddenly decreased due to the changes in lv output.The lv threshold and impedance temporarily stabilized resulting in an increase and recovery in device longevity.The crt-p remains in use.The patient was requested to come back in to the clinic to be reassessed at a later time.No patient complications have been reported as a result of this event.

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.

• Brand Name: ATTAIN PERFORMA MRI SURESCAN
• Type of Device: DRUG ELUTING PERMANENT LEFT VENTRICULAR (LV) PACEMAKER ELECTRODE
• Manufacturer (Section D): MPRI; road 149 km 56.3; villalba PR 00766
• MDR Report Key: 12120664
• MDR Text Key: 260022227
• Report Number: 2649622-2021-13520
• Device Sequence Number: 1
• Product Code: OJX
• Combination Product (y/n): N
• PMA/PMN Number: P080006
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Type of Report: Initial,Followup
• Report Date: 07/06/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Expiration Date: 02/07/2021
• Device Model Number: 429888
• Device Catalogue Number: 429888
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 07/06/2021
• Initial Date FDA Received: 07/06/2021
• Supplement Dates Manufacturer Received: 07/06/2021
• Supplement Dates FDA Received: 07/06/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: W4TR04 CRTP; W4TR04 CRTP.