SlimTip™ MN10350-90ARecalls & reported problems

Summary

The FDA's MAUDE database contains 21 adverse event reports that list this exact device (DI 05415067027146), received between Aug 16, 2019 and May 4, 2026 — classified as 21 injuries.

The most frequently reported specific device problem is “Patient-Device Incompatibility” (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 21 most recent of 21 reports, in the reporter's own words as published by the FDA.

• InjuryMay 4, 2026Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT FOLLOWING THE TRIAL PROCEDURE, THE PATIENT WAS HOSPITALIZED FOR DISTRESS AND CHEST PAIN. AS A RESULT, SURGICAL INTERVENTION WAS UNDERTAKEN ON (B)(6) 2026 WHEREIN THE LEAD WAS EXPLANTED TO ADDRESS THE ISSUE. THE PATIENT IS RECOVERING WELL.

  Patient problems: Pain; Shaking/Tremors

  MAUDE report 25072871 ↗
• InjurySep 11, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT DURING A DRG TRIAL ON (B)(6)2024, PATIENT EXPERIENCED HEADACHE DUE TO CEREBROSPINAL FLUID LEAKAGE. AS A RESULT, PATIENT WAS GIVEN A BLOOD PATCH AND THE HEADACHE HAS RESOLVED.

  Patient problems: Cerebrospinal Fluid Leakage; Headache

  MAUDE report 20196568 ↗
• InjurySep 11, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT DURING A DRG TRIAL ON (B)(6) 2024, PATIENT EXPERIENCED HEADACHE DUE TO CEREBROSPINAL FLUID LEAKAGE. AS A RESULT, PATIENT WAS GIVEN A BLOOD PATCH AND THE HEADACHE HAS RESOLVED.

  Patient problems: Cerebrospinal Fluid Leakage; Headache

  MAUDE report 20196357 ↗
• InjuryMay 18, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT WAS EXPERIENCING A POSITIONAL HEADACHE DUE TO A SUSPECTED WET TAP. A BLOOD PATCH WAS PERFORMED ON (B)(6)2023 TO ADDRESS THE ISSUE. IT WAS REPORTED THAT THE SYMPTOMS RESOLVED FOLLOWING THE BLOOD PATCH.

  Patient problems: Cerebrospinal Fluid Leakage

  MAUDE report 16955838 ↗
• InjurySep 15, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  RELATED MANUFACTURER REFERENCE NUMBER: 1627487-2021-17036. IT WAS REPORTED THE PATIENT HAD A TRIAL PROCEDURE ON (B)(6) 2021 AND DURING THE TRIAL PERIOD THE PATIENT HAD A HEART ATTACK ON (B)(6) 2021. THE PATIENT TURNED THE STIMULATION OFF ON THE AFTERNOON OF (B)(6) 2021. SURGICAL INTERVENTION TOOK PLACE WHEREIN THE TRIAL LEADS WERE REMOVED. PATIENT IS STABLE.

  Patient problems: Myocardial Infarction

  MAUDE report 12478110 ↗
• InjurySep 15, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  RELATED MANUFACTURER REFERENCE NUMBER: 1627487-2021-17038. IT WAS REPORTED THE PATIENT HAD A TRIAL PROCEDURE ON (B)(6) 2021 AND DURING THE TRIAL PERIOD THE PATIENT HAD A HEART ATTACK ON (B)(6) 2021. THE PATIENT TURNED THE STIMULATION OFF ON THE AFTERNOON OF (B)(6) 2021. SURGICAL INTERVENTION TOOK PLACE WHEREIN THE TRIAL LEADS WERE REMOVED. PATIENT IS STABLE.

  Patient problems: Myocardial Infarction

  MAUDE report 12478106 ↗
• InjuryApr 26, 2021Patient-Device Incompatibility; Patient-Device Incompatibility

  IT WAS REPORTED THAT THE TRIAL LEAD WAS UNABLE TO BE PLACED DUE TO PATIENT ANATOMY ON (B)(6) 2021. THE PHYSICIAN OPTED TO ABANDON THE PROCEDURE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11727747 ↗
• InjuryJun 11, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  RELATED MANUFACTURER REPORT NUMBER: 1627487-2020-21467. IT WAS REPORTED THE PATIENT THE PATIENT HAD A FEVER THAT LASTED TWO DAYS AND WAS VOMITING. PATIENT ALSO REPORTED A PULLING IN THEIR LOW BACK WHEN LOOKING DOWN. AS A RESULT, THE PATIENT HAD THEIR TRIAL SYSTEM REMOVED. THE FEVER LATER SUBSIDED AND THE PATIENT STOPPED VOMITING.

  Patient problems: Discomfort; Fever; Vomiting

  MAUDE report 10143636 ↗
• InjuryJun 11, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  RELATED MANUFACTURER REPORT NUMBER: 1627487-2020-21465. IT WAS REPORTED THE PATIENT THE PATIENT HAD A FEVER THAT LASTED TWO DAYS AND WAS VOMITING. PATIENT ALSO REPORTED A PULLING IN THEIR LOW BACK WHEN LOOKING DOWN. AS A RESULT, THE PATIENT HAD THEIR TRIAL SYSTEM REMOVED. THE FEVER LATER SUBSIDED AND THE PATIENT STOPPED VOMITING.

  Patient problems: Discomfort; Fever; Vomiting

  MAUDE report 10143584 ↗
• InjuryJun 10, 2020Material Twisted/Bent; Material Twisted/Bent

  RELATED MANUFACTURER REFERENCE NUMBER: 1627487-2020-21445. IT WAS REPORTED THE PATIENT WAS SEEN FOR A DRG RE-TRIAL ON (B)(6) 2020. THE CASE WAS ABANDONED DUE TO DIFFICULTY WITH SHEATHS DURING IMPLANT; THE SHEATHS WERE KINKED MULTIPLE TIMES.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10141371 ↗
• InjuryApr 17, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  DEVICE 2 OF 2. REFERENCE MFR. REPORT#: (B)(4). FOLLOW-UP REVEALED THE PATIENT'S ISSUE RESOLVED OVER TIME.

  Patient problems: Numbness

  MAUDE report 9974056 ↗
• InjuryApr 17, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  DEVICE 1 OF 2 REFERENCE MFR. REPORT#: 1627487-2020-04014. FOLLOW-UP REVEALED THE PATIENT'S ISSUE RESOLVED OVER TIME.

  Patient problems: Numbness

  MAUDE report 9974054 ↗
• InjuryApr 1, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  RELATED MANUFACTURER REFERENCE NUMBER: 1627487-2020-03091. IT WAS REPORTED THE PATIENT EXPERIENCED ATRIAL FIBRILLATION POST TRIAL IMPLANT PROCEDURE ON (B)(6) 2020. AS A RESULT, THE TRIAL LEADS WERE PULLED OUT.

  Patient problems: Atrial Fibrillation

  MAUDE report 9914072 ↗
• InjuryApr 1, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  RELATED MANUFACTURER REFERENCE NUMBER: 1627487-2020-03092. IT WAS REPORTED THE PATIENT EXPERIENCED ATRIAL FIBRILLATION POST TRIAL IMPLANT PROCEDURE ON (B)(6) 2020. AS A RESULT, THE TRIAL LEADS WERE PULLED OUT.

  Patient problems: Atrial Fibrillation

  MAUDE report 9914060 ↗
• InjuryMar 5, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  FOLLOW UP INFORMATION RECEIVED THAT ALL ISSUES HAVE RESOLVED.

  Patient problems: Cerebrospinal Fluid Leakage; Headache

  MAUDE report 9794731 ↗
• InjuryJan 24, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  FOLLOW-UP INFORMATION INDICATED THE PATIENT¿S ISSUE HAS BEEN RESOLVED.

  Patient problems: Low Oxygen Saturation

  MAUDE report 9629196 ↗
• InjuryOct 3, 2019Difficult to Remove; Difficult to Remove

  IT WAS REPORTED THAT DURING A TRIAL LEAD PROCEDURE, LEAD STYLET WAS STUCK IN THE PATIENT. THE STYLET WAS RETRACTED AS MUCH AS POSSIBLE HOWEVER WAS UNSUCCESSFUL. THE STYLET WAS CUT AS A RESULT TO RESOLVE THE ISSUE. THERE WERE NO COMPLICATIONS DURING THE PROCEDURE. PATIENT WAS STABLE.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9152167 ↗
• InjuryAug 30, 2019Use of Device Problem; Use of Device Problem

  RELATED MANUFACTURER REFERENCE NUMBER: 1627487-2019-09938. IT WAS REPORTED THAT THE PATIENT'S DRG TRIAL PROCEDURE WAS ABANDONED. THE PHYSICIAN COULD NOT PLACE THE LEADS DUE TO THE LEADS KINKING WHILE BEING PLACED. NO NEW PRODUCT WAS IMPLANTED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8951785 ↗
• InjuryAug 18, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  DEVICE 1 OF 2; REFERENCE MFR. REPORT#: 1627487-2019-09205.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8904499 ↗
• InjuryAug 18, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  DEVICE 2 OF 2 REFERENCE MFR. REPORT#: 1627487-2019-09204.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8904498 ↗
• InjuryAug 16, 2019Patient-Device Incompatibility; Patient-Device Incompatibility

  IT WAS REPORTED THAT DURING AN IMPLANT PROCEDURE ON (B)(6) 2019 THE PHYSICIAN WAS UNABLE TO IMPLANT THE DRG LEAD DUE TO PATIENT ANATOMY. AS A RESULT, THE PROCEDURE WAS ABANDONED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8903150 ↗