Plexa ProMRI DF-1 SD 65/18Recalls & reported problems

Summary

The FDA's MAUDE database contains 32 adverse event reports that list this exact device (DI 04035479151003), received between Jun 15, 2018 and Jan 30, 2026 — classified as 15 injuries, 17 malfunctions.

The most frequently reported specific device problem is “Ambient Noise Problem” (11 reports).

Reports come from manufacturers, hospitals and patients and are not verified by the FDA. A report does not prove the device caused the event, and counts can't be used to compare devices or estimate failure rates. How this data works · Data updated Oct 13, 2026.

Most reported problems

Recent adverse event reports

The 25 most recent of 32 reports, in the reporter's own words as published by the FDA.

• InjuryJan 30, 2026Fracture

  THIS LEAD WAS CAPPED DUE TO FRACTURE. SHOULD ADDITIONAL INFORMATION BE RECEIVED, THIS FILE WILL BE UPDATED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24223513 ↗
• MalfunctionJul 31, 2024Fracture; Ambient Noise Problem; Fracture; Ambient Noise Problem

  LEAD WAS EXPLANTED DUE TO NOISE. SUSPECTED FRACTURE. SHOULD ADDITIONAL INFORMATION BE RECEIVED, THIS FILE WILL BE UPDATED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19878252 ↗
• MalfunctionApr 15, 2024High impedance; High impedance

  THIS LEAD WAS EXPLANTED DUE TO SHOCK IMPEDANCE WAS GREATER THAN 150. SHOULD ADDITIONAL INFORMATION BE RECEIVED, THIS FILE WILL BE UPDATED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19104832 ↗
• MalfunctionMar 25, 2024Fracture; Ambient Noise Problem; Fracture; Ambient Noise Problem

  PATIENT RECEIVED 40J SHOCK FOR VT. POST SHOCK LEAD NOISE APPEARS ON FF, RA, AND RV CHANNELS. IN OFFICE CHECK SEEMED NORMAL. DOCTOR WILL DECIDE NEXT STEPS. DEVICE REMAINS IMPLANTED. SHOULD ADDITIONAL INFORMATION BE RECEIVED, THIS FILE WILL BE UPDATED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18969466 ↗
• InjuryMar 21, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  SYSTEM EXPLANTED DUE TO INFECTION. SHOULD ADDITIONAL INFORMATION BE RECEIVED, THIS FILE WILL BE UPDATED.

  Patient problems: Unspecified Infection

  MAUDE report 16588363 ↗
• MalfunctionJan 25, 2023Ambient Noise Problem; Ambient Noise Problem

  NOISE CAN BE SEEN VIA HMSC RECORDINGS BEGINNING ON (B)(6) 2023. PATIENT IS DEPENDENT. LEAD REMAINS IMPLANTED. NO ADVERSE EVENTS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16241368 ↗
• MalfunctionDec 7, 2022Ambient Noise Problem; Device Sensing Problem; Ambient Noise Problem; Device Sensing Problem

  NOISE ON FAR FIELD AND DROP IN RV SENSING AMPLITUDE SHOWS ON HM. LEAD REMAINS IMPLANTED. NO ADVERSE PATIENT EVENTS WERE REPORTED. SHOULD ADDITIONAL INFORMATION BECOME AVAILABLE, THIS FILE WILL BE UPDATED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15931450 ↗
• MalfunctionDec 2, 2022Pacing Problem; Ambient Noise Problem; Impedance Problem; Pacing Problem; Ambient Noise Problem; Impedance Problem

  THE SHOCK IMPEDANCE HAS TRENDED DOWN SINCE IMPLANT MAY 2022. PACING THRESHOLD HAS ALSO TRENDED LOW, AND AUTO THRESHOLD TEST HAS FAILED REPEATEDLY IN THE LAST MONTH CITING NO STABLE THRESHOLD. THE LAST VALUE OF SHOCK IMPEDANCE WAS 28 OHMS ON (B)(6) 2022. NOISE CAN BE SEEN IN RECORDINGS ON (B)(6) 2022 AND (B)(6) 2022. LEAD REMAINS IMPLANTED. NO ADVERSE PATIENT EVENTS WERE REPORTED. SHOULD ADDITIONAL INFORMATION BECOME AVAILABLE, THIS FILE WILL BE UPDATED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15910052 ↗
• MalfunctionOct 31, 2022Over-Sensing; Ambient Noise Problem; Over-Sensing; Ambient Noise Problem

  POSSIBLE NOISE AND OVERSENSING ON RV LEAD WERE REPORTED. ADVISED TO EVALUATE FURTHER. LEAD CURRENTLY REMAINS IMPLANTED. NO ADVERSE PATIENT EVENTS WERE REPORTED. SHOULD ADDITIONAL INFORMATION BE RECEIVED, THIS FILE WILL BE UPDATED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15699184 ↗
• MalfunctionAug 29, 2022Fracture; Fracture

  THIS RV LEAD WAS EXPLANTED DUE TO SUSPECTED FRACTURE IN BOTH PACE/SENSE ASPECT AS WELL AS SHOCK ASPECT. NO ADVERSE PATIENT EVENTS WERE REPORTED. SHOULD ADDITIONAL INFORMATION BE RECEIVED, THIS FILE WILL BE UPDATED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15317012 ↗
• InjuryAug 11, 2022Inappropriate/Inadequate Shock/Stimulation; Ambient Noise Problem; Inappropriate/Inadequate Shock/Stimulation; Ambient Noise Problem

  THIS LEAD WAS EXPLANTED DUE TO NOISE AND INAPPROPRIATE SHOCKS. SHOULD ADDITIONAL INFORMATION BE RECEIVED, THIS FILE WILL BE UPDATED.

  Patient problems: Shock from Patient Lead(s)

  MAUDE report 15214543 ↗
• MalfunctionMar 24, 2022High impedance; High impedance

  SCV COIL SHOCK IMPEDANCE READING AT 190OHMS. CLINICIAN TO PROGRAM SO RV COIL ONLY. LEAD REMAINS IMPLANTED. NO ADVERSE PATIENT EVENTS WERE REPORTED. SHOULD ADDITIONAL INFORMATION BECOME AVAILABLE, THIS FILE WILL BE UPDATED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13871744 ↗
• MalfunctionMar 17, 2022High impedance; Ambient Noise Problem; High impedance; Ambient Noise Problem

  THIS LEAD WAS CAPPED DUE TO NOISE AND HIGH PACING IMPEDANCE. NO ADVERSE PATIENT EVENTS WERE REPORTED. SHOULD ADDITIONAL INFORMATION BECOME AVAILABLE, THIS FILE WILL BE UPDATED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13792806 ↗
• InjuryMar 3, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THIS SYSTEM WAS EXPLANTED DUE TO INFECTION. SHOULD ADDITIONAL INFORMATION BECOME AVAILABLE, THIS FILE WILL BE UPDATED.

  Patient problems: Unspecified Infection

  MAUDE report 13660619 ↗
• MalfunctionMar 1, 2022Fracture; High impedance; Ambient Noise Problem; Fracture; High impedance; Ambient Noise Problem

  NOISE AND HIGH SHOCK IMPEDANCES WERE REPORTED ON THIS LEAD. PHYSICIAN WAS UNABLE TO REPRODUCE NOISE WITH POSTURALS AND POCKET MANIPULATION. LEAD WAS EXPLANTED. NO ADVERSE PATIENT EVENTS WERE REPORTED. SHOULD ADDITIONAL INFORMATION BE RECEIVED, THIS FILE WILL BE UPDATED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13638759 ↗
• MalfunctionJan 31, 2022Fracture; Ambient Noise Problem; Fracture; Ambient Noise Problem

  THERE WERE DEVICE RECORDINGS OF NOISE ON THE IEGM LEADING TO MULTIPLE NSVT RECORDINGS AND ONE ABORTED SHOCK. SENSING, IMPEDANCE, AND THRESHOLD SHOWED NO CHANGES AND WERE STABLE AND IN RANGE. THE LEAD WAS CUT AT THE YOLK AND CAPPED AND A NEW RV LEAD WAS PLACED. THE LEAD SHOWED A CUT OF THE INSULATION ON THE RV COIL PORTION NEAR THE HEADER PIN (WHICH WOULD BE UNRELATED TO THE NOISE OBSERVED). IT WILL BE RETURNED TO BIOTRONIK FOR ANALYSIS. NO ADVERSE PATIENT EVENTS WERE REPORTED. SHOULD ADDITIONAL INFORMATION BECOME AVAILABLE, THIS FILE WILL BE UPDATED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13405891 ↗
• InjuryOct 22, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  LEAD EXPLANTED DUE TO PATIENT EXPERIENCING CARDIOGENIC SHOCK, SEPSIS, AND VEGETATION ON LEAD. SHOULD ADDITIONAL INFORMATION BECOME AVAILABLE, IT WILL BE ADDED TO THIS FILE.

  Patient problems: Cardiogenic Shock; Sepsis; Unspecified Infection

  MAUDE report 12685448 ↗
• MalfunctionJun 16, 2021Ambient Noise Problem; Ambient Noise Problem

  LEAD REMAINS IMPLANTED. APPARENT PERSISTENT NOISE ON ATRIAL LEAD. FULL LEAD EVALUATION RECOMMENDED. NO ADVERSE PATIENT EVENTS REPORTED. SHOULD ADDITIONAL INFORMATION BECOME AVAILABLE, IT WILL BE ADDED TO THIS FILE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12014085 ↗
• InjuryNov 17, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  LEAD WAS EXPLANTED DUE TO INFECTION. SHOULD ADDITIONAL INFORMATION BECOME AVAILABLE, THIS REPORT WILL BE UPDATED.

  Patient problems: Unspecified Infection

  MAUDE report 10856939 ↗
• MalfunctionSep 16, 2020High impedance; High impedance

  SHOCK IMPEDANCE > 150 OHMS ON HOME MONITORING. PATIENT HAD PREVIOUS LEAD EXTRACTED, AND THIS LEAD IMPLANTED ON (B)(6) 2020. 2 DAYS AFTER IMPLANT LEAD BEGAN REPORTING SHOCK IMPEDANCE <150. PATIENT BROUGHT TO OFFICE ON (B)(6) 2020, AND IN OFFICE 5/5 MEASUREMENTS SHOWED IMPEDANCE IN NORMAL RANGE. NO NOISE COULD BE ELICITED AND POSTURAL TESTING WAS ALSO COMPLETED. LEAD REMAINS IMPLANTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 10542291 ↗
• InjuryMay 22, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  SYSTEM WAS EXPLANTED DUE TO INFECTION. SHOULD ADDITIONAL INFORMATION BE RECEIVED, THIS FILE WILL BE UPDATED.

  Patient problems: Unspecified Infection

  MAUDE report 10083576 ↗
• MalfunctionFeb 28, 2020Device Damaged by Another Device; Device Damaged by Another Device

  SYSTEM WAS EXPLANTED AND REPLACED DUE TO LV LEAD NON FUNCTIONING DUE TO DISLODGEMENT. DURING EXTRACTION, RA AND RV LEAD WERE DAMAGED. PHYSICIAN CHOICE TO REPLACE ICD DURING LEAD REVISION. NO ADVERSE PATIENT EVENTS WERE REPORTED. SHOULD ADDITIONAL INFORMATION BECOME AVAILABLE, THIS FILE WILL BE UPDATED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 9769393 ↗
• InjurySep 25, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THIS SYSTEM WAS EXPLANTED DUE TO POCKET EROSION. NEW SYSTEM WAS NOT IMPLANTED. SHOULD ADDITIONAL INFORMATION BECOME AVAILABLE, THIS FILE WILL BE UPDATED.

  Patient problems: Pocket Erosion

  MAUDE report 9120880 ↗
• InjurySep 11, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  EXPLANTED DUE TO NON HEALING INCISION. SHOULD ADDITIONAL INFORMATION BECOME AVAILABLE, THIS FILE WILL BE UPDATED.

  Patient problems: Impaired Healing; Unspecified Infection

  MAUDE report 8992371 ↗
• InjuryJun 3, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  SYSTEM EXPLANTED DUE TO INFECTION. THE SYSTEM HAS NOT BEEN REPLACED AT THIS TIME. SHOULD ADDITIONAL INFORMATION BECOME AVAILABLE, THIS FILE WILL BE UPDATED.

  Patient problems: Unspecified Infection

  MAUDE report 8662972 ↗