SlimTip™ MN10350-50ARecalls & reported problems

Summary

The FDA's MAUDE database contains 373 adverse event reports that list this exact device (DI 05415067027139), received between Jun 29, 2018 and Sep 22, 2026 — classified as 3 deaths, 368 injuries, 2 malfunctions.

The most frequently reported specific device problem is “Patient-Device Incompatibility” (22 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. What reports can and can't tell you · How this data works · Data updated Oct 16, 2026.

Most reported problems

Recent adverse event reports

The 25 most recent of 373 reports, in the reporter's own words as published by the FDA.

• InjurySep 22, 2026Adverse Event Without Identified Device or Use Problem

  Patient symptomsOn 24AUG2026 (b)(6) (Litigation Department) emailed NMD Complaints reporting:Patient reported negligent placement of the dual lead arrangement (2 leads), 4 contact lead placement for spinal modulation of DRG (spinal cord stimulator) on (b)(6) 2023; during the multiple attempts to pass the catheter during the placement of the spinal cord stimulator, negligently causing trauma that resulted in swelling of the tissue around the nerve that caused nerve impingement; negligently causing cauda equina syndrome. Patient was experiencing paresthesia in the foot associated with the inability to urinate and the inability to attain an erection. On (b)(6) 2023 doctor presented for an emergency visit for worsening numbness into right leg up to right hip, continued right leg tingling, some mild urine incontinence at the end of urination. Patient had an MRI scan, negligently physician failed to insure that the patient underwent spinal cord decompression within 24 hours of the onset of symptoms; all of which resulted in permanent neurological injuries that include severe pain in the lower extremities associated with weakness, impotence and urinary and bowel incontinence. PER (b)(4) d

  Patient problems: Fecal Incontinence; Urinary Incontinence

  MAUDE report 50859453 ↗
• InjurySep 22, 2026Adverse Event Without Identified Device or Use Problem

  It was reported that the patient experienced hyperventilation and trouble breathing following trail lead placement which required an emergency room visit. The breathing issue resolved and trail completed. It cannot be determined which lead contributed to the event.

  Patient problems: Decreased Respiratory Rate

  MAUDE report 50857484 ↗
• InjurySep 21, 2026Adverse Event Without Identified Device or Use Problem

  It was reported that the patient experienced leg weakness when their trial leads were explanted on (b)(6) 2026. Symptoms have resolved. It is unknown which lead the allegation is against.

  Patient problems: Muscle Weakness/Atrophy

  MAUDE report 50845531 ↗
• InjuryJun 5, 2026Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT PRIOR TO A TRIAL PROCEDURE, THE PATIENT ASPIRATED AND WAS NOT BREATHING. AS A RESULT, THE PHYSICIAN ABANDONED THE PROCEDURE. THE PATIENT IS NOW STABLE.

  Patient problems: Aspiration/Inhalation

  MAUDE report 25403937 ↗
• InjuryFeb 27, 2026Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT PATIENT EXPERIENCED HEADACHES FOLLOWING TRIAL PROCEDURE, PATIENT HAD CSF LEAK. AS A RESULT, A BLOOD PATCH WAS PERFORMED TO ADDRESS THE ISSUE. PATIENT IS DOING WELL POST OP. THE INVESTIGATION WAS UNABLE TO DETERMINE THE LEAD THAT IS ASSOCIATED WITH THE ISSUE.

  Patient problems: Cerebrospinal Fluid Leakage; Headache

  MAUDE report 24476527 ↗
• InjuryFeb 11, 2026Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT DURING A TRIAL IMPLANT PROCEDURE THE PATIENT STOPPED BREATHING. AS A RESULT, BOTH LEADS WERE EXPLANTED ON (B)(6) 2026, AND THE PROCEDURE WAS ABANDONED TO ADDRESS THE ISSUE.

  Patient problems: Respiratory Arrest

  MAUDE report 24318563 ↗
• InjuryFeb 11, 2026Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT DURING A TRIAL IMPLANT PROCEDURE THE PATIENT STOPPED BREATHING. AS A RESULT, BOTH LEADS WERE EXPLANTED ON (B)(6) 2026, AND THE PROCEDURE WAS ABANDONED TO ADDRESS THE ISSUE.

  Patient problems: Respiratory Arrest

  MAUDE report 24318558 ↗
• InjuryJan 14, 2026Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED PATIENT EXPERIENCED A HEART ATTACK DURING THE TRIAL PERIOD. A STENT WAS PLACED AND PATIENT WAS HOSPITALIZED. IT IS UNKNOWN WHICH LEAD CONTRIBUTED TO THE EVENT.

  Patient problems: Myocardial Infarction

  MAUDE report 24068022 ↗
• InjuryJan 7, 2026Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT EXPERIENCED A CSF LEAKAGE RESULTING IN HEADACHE. AS SUCH, A BLOOD PATCH WAS PERFORMED RESOLVE THE SYMPTOMS. THE TRIAL WAS ABORTED, AND THE LEADS WERE REMOVED TO ADDRESS THE ISSUE. INVESTIGATION WAS UNABLE TO DETERMINE WHICH OF THE LEADS ATTRIBUTED TO THE ISSUE.

  Patient problems: Headache

  MAUDE report 23991891 ↗
• InjuryDec 24, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED PATIENT COMPLAINED OF HEADACHE FOLLOWING A TRIAL PROCEDURE. THERE WAS FLUID OBSERVED EXITING THE NEED DURING THE PROCEDURE AND HEADACHE RESOLVED AFTER DISCHARGE. HOWEVER, PATIENT EXPERIENCED WEAKNESS IN THE LEG AND WENT TO EMERGENCY FOR EVALUATION. SURGICAL INTERVENTION WAS UNDERTAKEN WHEREIN THE LEAD WAS REMOVED TO ADDRESS THE ISSUE.

  Patient problems: Muscle Weakness/Atrophy; Pain

  MAUDE report 23891280 ↗
• InjuryDec 24, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED PATIENT COMPLAINED OF HEADACHE FOLLOWING A TRIAL PROCEDURE. THERE WAS FLUID OBSERVED EXITING THE NEED DURING THE PROCEDURE AND HEADACHE RESOLVED AFTER DISCHARGE. HOWEVER, PATIENT EXPERIENCED WEAKNESS IN THE LEG AND WENT TO EMERGENCY FOR EVALUATION. SURGICAL INTERVENTION WAS UNDERTAKEN WHEREIN THE LEAD WAS REMOVED TO ADDRESS THE ISSUE.

  Patient problems: Cerebrospinal Fluid Leakage; Headache

  MAUDE report 23891277 ↗
• InjuryDec 23, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT DURING A DRG TRIAL THE PATIENT EXPERIENCED BURNING SENSATIONS IN THEIR FEET. AS A RESULT, SURGICAL INTERVENTION WAS UNDERTAKEN ON (B)(6) 2025 WHEREIN THE TRIAL LEADS WERE PULLED ADDRESS THE ISSUE. IT IS UNKNOWN WHICH TRIAL LEAD CAUSED THE BURNING SENSATIONS.

  Patient problems: Burning Sensation; Implant Pain

  MAUDE report 23881572 ↗
• InjuryNov 14, 2025High impedance; Separation Failure; High impedance; Separation Failure

  IT WAS REPORTED DURING A DRG TRIAL, THERE WAS HIGH IMPEDANCES, AND ONE LEAD WAS STUCK. AS A RESULT, THE LEAD WAS REMOVED AND REPLACED. THE PROCEDURE WAS COMPLETED WITH A NEW TRIAL LEAD.

  Patient problems: Inadequate Pain Relief; No Clinical Signs, Symptoms or Conditions

  MAUDE report 23560479 ↗
• InjuryOct 27, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT DURING THE TRIAL PROCEDURE ON (B)(6) 2025, THE PATIENT EXPERIENCED VASOVAGAL SYNCOPE. IN TURN, THE PHYSICIAN DECIDED TO ABORT THE PROCEDURE. THE PATIENT IS FEELING BETTER AND HAS NO FURTHER ISSUES.

  Patient problems: Syncope/Fainting

  MAUDE report 23391670 ↗
• InjuryOct 23, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT DURING A ROUTINE TRIAL PROCEDURE, THE PATIENT STOPPED BREATHING AND THE TRIAL WAS ABORTED. PATIENT WAS WOKEN UP WITHOUT FURTHER COMPLICATIONS.

  Patient problems: Respiratory Arrest

  MAUDE report 23372183 ↗
• InjuryOct 19, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT DURING A TRIAL LEAD IMPLANT PROCEDURE THE PATIENT EXPERIENCED A SEIZURE. IT WAS REPORTED THAT THE PATIENT WAS DOING WELL AFTERWARDS AND THE TRIAL WAS CONTINUED SUCCESSFULLY. IT IS UNKNOWN WHICH LEAD CONTRIBUTED TO THE ISSUE.

  Patient problems: Convulsion/Seizure

  MAUDE report 23333645 ↗
• InjuryJul 29, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT DURING A TRIAL PROCEDURE ON (B)(6) 2025 [RELATED MANUFACTURER REFERENCE NUMBER: 3006705815-2025-05546] THE PATIENT EXPERIENCED A CSF LEAK. THE PATIENT EXPERIENCED HEADACHES, AND AS A RESULT THE LEADS WERE EXPLANTED AND (B)(6) 2025. THE PATIENT'S SYMPTOMS HAVE SINCE RESOLVED.

  Patient problems: Cerebrospinal Fluid Leakage; Headache

  MAUDE report 22653903 ↗
• InjuryJul 24, 2025Use of Device Problem; Use of Device Problem

  IT WAS REPORTED THAT FOLLOWING A RECENT TRIAL IMPLANT PROCEDURE, PATIENT EXPERIENCED INEFFECTIVE THERAPY AND REMOVED THEIR TRIAL LEADS ON (B)(6) 2025. X-RAY IMAGING REVEALED THAT PART OF ONE LEAD REMAINS IMPLANTED IN THE PATIENT. AS A RESULT, SURGICAL INTERVENTION MAY BE UNDERTAKEN TO ADDRESS THE ISSUE. IT IS UNKNOWN WHICH LEAD IS IMPACTED.

  Patient problems: Foreign Body In Patient

  MAUDE report 22589548 ↗
• InjuryJul 17, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT EXPERIENCED TROUBLE WITH BREATHING DURING A TRIAL PROCEDURE AND EMERGENCY SERVICES WERE CALLED TO ADDRESS THE ISSUE. THE PATIENT WAS STABLE LATER THAT DAY.

  Patient problems: Decreased Respiratory Rate

  MAUDE report 22538593 ↗
• InjuryJul 11, 2025Material Fragmentation; Use of Device Problem; Material Fragmentation; Use of Device Problem

  IT WAS REPORTED THAT DURING A TRIAL PROCEDURE ON (B)(6) 2025, THE CURVE OF THE SHEATH SHEARED OFF WHEN THE PHYSICIAN ATTEMPTED TO PULL THE SHEATH BACK THROUGH THE NEEDLE AFTER TOO MUCH FORCE WAS APPLIED WHEN ATTEMPTING TO SURPASS LIGAMENTS. AS A RESULT, THE PROCEDURE WAS ABANDONED, AND A PORTION OF THE SHEATH REMAINS IMPLANTED. AS A RESULT, SURGICAL INTERVENTION MAY BE UNDERTAKEN TO REMOVE THE REMAINDER OF THE SHEATH.

  Patient problems: Device Embedded In Tissue or Plaque

  MAUDE report 22477886 ↗
• InjuryJul 2, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT EXPERIENCED AN INCREASE IN PAIN FOLLOWING A TRIAL PROCEDURE ON 11 JUNE 2025. THE PHYSICIAN DETERMINED THE L1 LEAD WAS CAUSING DEVICE RELATED PAIN AND EXPLANTED THE LEADS ON (B)(6) 2025.

  Patient problems: Pain

  MAUDE report 22390786 ↗
• InjuryJun 13, 2025Use of Device Problem; Use of Device Problem

  ADDITIONAL INFORMATION REPORTED PATIENT UNDERWENT SURGICAL INTERVENTION ON AN UNKNOWN DATE IN (B)(6) 2025 WHEREIN THE REMAINING OF LEAD WAS EXPLANTED TO ADDRESS THE ISSUE.

  Patient problems: Device Embedded In Tissue or Plaque

  MAUDE report 22206273 ↗
• InjuryJun 5, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT FOLLOWING A TRIAL IMPLANT PROCEDURE, THE PATIENT EXPERIENCED A CEREBROSPINAL FLUID LEAK. THE PATIENT ALSO EXPERIENCED A HEADACHE AND NECK PAIN. THE TRIAL SYSTEM WAS REMOVED ON (B)(6) 2025. IT IS UNKNOWN WHICH LEAD WAS AT FAULT.

  Patient problems: Cerebrospinal Fluid Leakage; Headache; Pain

  MAUDE report 22155094 ↗
• InjuryMay 12, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT EXPERIENCED A SEVERE HEADACHE FOLLOWING A TRIAL PROCEDURE. AS A RESULT, THE PATIENT WAS TRANSPORTED TO THE HOSPITAL FOR FURTHER EVALUATION. ADDITIONAL INFORMATION INDICATES THE HEADACHE HAS SINCE BEEN RESOLVED.

  Patient problems: Headache

  MAUDE report 22003917 ↗
• InjuryMay 9, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT DID NOT SUSPEND BLOOD THINNER MEDICATION PRIOR TO TRIAL PROCEDURE ON (B)(6) 2025. PATIENT REQUIRED HOSPITALIZATION TO MONITOR BLEEDING. PATIENT'S SCANS CAME BACK CLEAR AND WAS SENT HOME. IT IS UNKNOWN WHICH LEAD WAS AT FAULT.

  Patient problems: Hemorrhage/Blood Loss/Bleeding

  MAUDE report 21999294 ↗