Plexa ProMRI SD 75/18Recalls & reported problems

BIOTRONIK SE & Co. KG · Class 3 · Implant

Adverse event reports: 1
Deaths reported: 0
Injuries reported: 0
Recalls naming it: 0

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 04035479140007), received between Nov 20, 2025 and Nov 20, 2025 — classified as 1 malfunction.

The most frequently reported specific device problem is “Ambient Noise Problem” (1 report).

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.

Reports received per month

Last 36 months. The most recent month may be incomplete.

Most reported problems

Device problems

Ambient Noise Problem1
Device Sensing Problem1
High Capture Threshold1
High impedance1

Patient problems

No Clinical Signs, Symptoms or Conditions1

Recent adverse event reports

The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.

MalfunctionNov 20, 2025High impedance; Ambient Noise Problem; Device Sensing Problem; High Capture Threshold; High impedance; Ambient Noise Problem; Device Sensing Problem; High Capture Threshold
LEAD SHOWS SUDDEN INCREASE IN PACING IMPEDANCE, DECREASE IN SENSING AND INCREASE IN THRESHOLD. RECORDINGS SHOW PRESENCE OF NOISE AND SUDDEN INCREASE OF SHORT INTERVAL COUNTS. LEAD REMAINS IMPLANTED. SHOULD ADDITIONAL INFORMATION BE RECEIVED THIS FILE WILL BE UPDATED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23612226 ↗

Device details

UDI-DI	`04035479140007`
Brand	Plexa ProMRI
Model	SD 75/18
Catalog no.	402264
Company	BIOTRONIK SE & Co. KG
Product code	NVY · Permanent defibrillator electrodes
Class	Class 3
FDA submission	P980023
Implant	Yes
Rx / OTC	Prescription
Single use	Yes
Sterile	Yes
MRI safety	MR Conditional
Status	In Commercial Distribution
Record updated	Feb 5, 2021

Device type (GMDN): Endocardial defibrillation lead

An implantable flexible wire with an electrode, insulated with non-conductive material except at its ends, intended to function as an electrical conductor to transmit defibrillation impulses from an implanted cardioverter-defibrillator (ICD) [automatic implantable cardioverter-defibrillator (AICD)] to the endocardium of the right ventricle. It may also be intended to transmit pacing impulses from a cardiac resynchronization therapy (CRT) pulse generator, AICD, or other pacing device. It is typically impregnated with a steroid (e.g., dexamethasone) intended to elute into the tissues to reduce inflammation.

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Sources: FDA GUDID, MAUDE and Medical Device Recalls via openFDA. openFDA data is not validated for clinical or regulatory use.