NA 2303Recalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 05415067029430), received between Oct 4, 2019 and Jun 20, 2023 — classified as 3 injuries.

The most frequently reported specific device problem is “Low impedance” (2 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 3 most recent of 3 reports, in the reporter's own words as published by the FDA.

• InjuryJun 20, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  RELATED MANUFACTURER REFERENCE NUMBER: 1627487-2023-02816. IT WAS REPORTED THE PATIENT'S ADAPTER AND IPG ERODED THROUGH THE SKIN THEREFORE THEY WERE EXPLANTED TO ADDRESS THE ISSUE.

  Patient problems: Pocket Erosion

  MAUDE report 17165201 ↗
• InjuryOct 4, 2019Low impedance; Low impedance

  REFERENCE MFR. REPORT:: 1627487-2019-11070. IT WAS REPORTED PATIENT HAD LOW IMPEDANCES FROM THE TIME HE HAD A FALL APPROXIMATELY IN (B)(6) 2019. IT WAS THOUGHT THAT THE ISSUE HAD RESOLVED BUT IT WAS NOT AND RECENTLY DURING PROGRAMMING APPROXIMATELY ON (B)(6) 2019 THE ISSUE WAS CONFIRMED TO STILL BE PRESENT. TO ADDRESS THIS ISSUE THE LEAD EXTENSIONS WERE REPLACED. HOWEVER, STILL THE LOW IMPEDANCE ISSUE PERSISTED BUT EFFECTIVE THERAPY WAS ACHIEVED POST OPERATIVELY.

  Patient problems: Inadequate Pain Relief

  MAUDE report 9155887 ↗
• InjuryOct 4, 2019Low impedance; Low impedance

  REFERENCE MFR. REPORT: 1627487-2019-11085. IT WAS REPORTED PATIENT HAD LOW IMPEDANCES FROM THE TIME HE HAD A FALL APPROXIMATELY IN (B)(6) 2019 . IT WAS THOUGHT THAT THE ISSUE HAD RESOLVED BUT IT WAS NOT AND RECENTLY DURING PROGRAMMING APPROXIMATELY ON (B)(6) 2019 THE ISSUE WAS CONFIRMED TO STILL BE PRESENT. TO ADDRESS THIS ISSUE THE LEAD EXTENSIONS WERE REPLACED. HOWEVER, STILL THE LOW IMPEDANCE ISSUE PERSISTED BUT EFFECTIVE THERAPY WAS ACHIEVED POST OPERATIVELY .

  Patient problems: Inadequate Pain Relief

  MAUDE report 9155885 ↗