Senza® NIPG1500Recalls & reported problems

Summary

The FDA's MAUDE database contains 1,792 adverse event reports that list this exact device (DI 00813426020015), received between Nov 23, 2015 and Sep 25, 2026 — classified as 432 deaths, 1,357 injuries, 3 malfunctions.

The most frequently reported specific device problem is “Insufficient Device Problem Information” (60 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 1,792 reports, in the reporter's own words as published by the FDA.

• InjurySep 25, 2026Adverse Event Without Identified Device or Use Problem

  It was reported that the patient experienced discomfort at the implant site. A medical assessment regarding the nature of the reported issue was not available. The patient had the device removed, and no further complications have been reported related to this event.

  Patient problems: Discomfort

  MAUDE report 50899689 ↗
• InjurySep 22, 2026Adverse Event Without Identified Device or Use Problem

  It was reported that the patient experienced back pain. A medical assessment from the physician regarding the cause of the reported event was not available. The patient was hospitalized. There have been no reports of further complications regarding this event.

  Patient problems: Back pain

  MAUDE report 50855093 ↗
• InjuryJun 23, 2026Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT DEVELOPED SEPSIS. THE CULTURE REPORT IDENTIFIED METHICILLIN-SUSCEPTIBLE STAPHYLOCOCCUS AUREUS (MSSA). A MEDICAL ASSESSMENT FROM THE PHYSICIAN REGARDING THE NATURE AND SOURCE OF THE INFECTION WAS NOT AVAILABLE. THE PATIENT WAS HOSPITALIZED AND TREATED WITH INTRAVENOUS ANTIBIOTICS. THERE HAVE BEEN NO REPORTS OF FURTHER COMPLICATIONS RELATED TO THIS EVENT.

  Patient problems: Bacterial Infection; Sepsis

  MAUDE report 25599992 ↗
• InjuryJun 4, 2026Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT EXPERIENCED HEAT SENSATION DURING AN MRI TEST. AN HCP ASSESSMENT REGARDING THE CAUSE OF THE REPORTED EVENT WAS NOT AVAILABLE. THE MRI TEST WAS ABORTED. THERE HAVE BEEN NO REPORTS OF FURTHER COMPLICATIONS REGARDING THIS EVENT.

  Patient problems: Burning Sensation

  MAUDE report 25394609 ↗
• InjuryMay 5, 2026Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT EXPERIENCED NUMBNESS ON THE RIGHT ANKLE. THE PATIENT HAD THE DEVICE EXPLANTED. THERE HAVE BEEN NO REPORTS OF FURTHER COMPLICATIONS REGARDING THIS EVENT.

  Patient problems: Numbness

  MAUDE report 25085639 ↗
• InjuryMay 5, 2026Fluid/Blood Leak

  IT WAS REPORTED THAT THE PATIENT EXPERIENCED A FLUID DISCHARGE FROM THE DEVICE. A MEDICAL ASSESSMENT REGARDING THE NATURE OF THE REPORTED ISSUE WAS NOT AVAILABLE. THE PATIENT HAD THE DEVICE REMOVED, AND NO FURTHER COMPLICATIONS HAVE BEEN REPORTED RELATED TO THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25084472 ↗
• InjuryApr 30, 2026Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT EXPERIENCED DEBILITATING PAIN AND DISCOMFORT AT BOTH THE POCKET SITE AND LEAD SITE. THE DEVICE WAS SUBSEQUENTLY REMOVED, AND THE ISSUE WAS RESOLVED. NO FURTHER COMPLICATIONS HAVE BEEN REPORTED IN RELATION TO THIS EVENT.

  Patient problems: Discomfort; Implant Pain

  MAUDE report 25048690 ↗
• InjuryApr 29, 2026Adverse Event Without Identified Device or Use Problem

  THE PATIENT WAS REPORTED TO HAVE EXPERIENCED WORSENING PAIN, NUMBNESS IN THE EXTREMITIES, MUSCLE WEAKNESS, FALLS RESULTING IN INJURIES, URINARY INCONTINENCE, BLOOD CLOTS, AND ELECTRIC SHOCK-LIKE SENSATIONS. THE DEVICE WAS SUBSEQUENTLY REMOVED. THERE HAVE BEEN NO FURTHER COMPLICATIONS REPORTED FOLLOWING THIS EVENT.

  Patient problems: Fall; Muscle Weakness/Atrophy; Numbness; Pain; Thrombosis/Thrombus; Urinary Incontinence

  MAUDE report 25031399 ↗
• InjuryApr 9, 2026Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT'S DEVICE WAS REMOVED BUT THE LEADS WERE LEFT IN PLACE. AN HCP ASSESSMENT REGARDING THE CAUSE OF THE REPORTED EVENT WAS NOT AVAILABLE. THERE WERE NO REPORTS OF DEVICE-RELATED ISSUES PRIOR TO THE DEVICE REMOVAL. THERE HAVE BEEN NO REPORTS OF FURTHER COMPLICATIONS REGARDING THIS EVENT.

  Patient problems: Insufficient Information

  MAUDE report 24832803 ↗
• InjuryApr 8, 2026Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT'S DEVICE WAS REMOVED. AN HCP ASSESSMENT REGARDING THE CAUSE OF THE REPORTED EVENT WAS NOT AVAILABLE. THERE WERE NO REPORTS OF DEVICE-RELATED ISSUES PRIOR TO THE DEVICE REMOVAL. THERE HAVE BEEN NO REPORTS OF FURTHER COMPLICATIONS REGARDING THIS EVENT.

  Patient problems: Insufficient Information

  MAUDE report 24823803 ↗
• InjuryMar 30, 2026Adverse Event Without Identified Device or Use Problem; Insufficient Device Problem Information

  IT WAS REPORTED THAT THE PATIENT'S DEVICE WAS REMOVED. ADDITIONAL INFORMATION REGARDING THE NATURE OF THE DEVICE REMOVAL WAS NOT AVAILABLE. THERE WERE NO REPORTS OF DEVICE-RELATED ISSUES PRIOR TO THE DEVICE REMOVAL.

  Patient problems: Insufficient Information

  MAUDE report 24713144 ↗
• InjuryMar 26, 2026Adverse Event Without Identified Device or Use Problem; Insufficient Device Problem Information

  IT WAS REPORTED THAT THE PATIENT'S DEVICE WAS REMOVED. AN HCP ASSESSMENT REGARDING THE CAUSE OF THE REPORTED EVENT WAS NOT AVAILABLE. THERE WERE NO REPORTS OF DEVICE-RELATED ISSUES PRIOR TO THE DEVICE REMOVAL. THERE HAVE BEEN NO REPORTS OF FURTHER COMPLICATIONS REGARDING THIS EVENT.

  Patient problems: Insufficient Information

  MAUDE report 24708501 ↗
• InjuryMar 24, 2026Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT'S DEVICE WAS REMOVED. ADDITIONAL INFORMATION REGARDING THE NATURE OF THE DEVICE REMOVAL WAS NOT AVAILABLE. THERE WERE NO REPORTS OF DEVICE-RELATED ISSUES PRIOR TO THE DEVICE REMOVAL.

  Patient problems: Insufficient Information

  MAUDE report 24675118 ↗
• InjuryMar 20, 2026Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT'S DEVICE WAS REMOVED. ADDITIONAL INFORMATION REGARDING THE NATURE OF THE DEVICE REMOVAL WAS NOT AVAILABLE. THERE WERE NO REPORTS OF DEVICE-RELATED ISSUES PRIOR TO THE DEVICE REMOVAL.

  Patient problems: Insufficient Information

  MAUDE report 24650298 ↗
• InjuryMar 10, 2026Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT EXPERIENCED SHOCK SENSATIONS. A MEDICAL ASSESSMENT FROM THE PHYSICIAN REGARDING THE CAUSE OF THESE SYMPTOMS WAS NOT AVAILABLE. THE DEVICE WAS REMOVED. NO FURTHER COMPLICATIONS HAVE BEEN REPORTED REGARDING THIS EVENT.

  Patient problems: Pain

  MAUDE report 24563376 ↗
• InjuryMar 6, 2026Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT'S DEVICE WAS REMOVED. ADDITIONAL INFORMATION REGARDING THE NATURE OF THE DEVICE REMOVAL WAS NOT AVAILABLE. THERE WERE NO REPORTS OF DEVICE-RELATED ISSUES PRIOR TO THE DEVICE REMOVAL.

  Patient problems: Insufficient Information

  MAUDE report 24532507 ↗
• InjuryFeb 13, 2026Adverse Event Without Identified Device or Use Problem

  THE PATIENT PRESENTED FOR A SYSTEM REVISION PROCEDURE INVOLVING REPLACEMENT OF THE EXISTING DEVICE AND LEADS DUE TO A REDUCED THERAPEUTIC EFFECTIVENESS AND DIMINISHING DEVICE CHARGE RETENTION. DURING THE PROCEDURE, AFTER THE SURGEON OPENED THE POCKET, ABNORMAL TISSUE FINDINGS WERE OBSERVED. THE TISSUE SURROUNDING THE DEVICE AND THE EXCESS COILED PORTIONS OF THE PREVIOUSLY IMPLANTED LEADS DEMONSTRATED NOTABLE DISCOLORATION. THE SURGEON DESCRIBED THE TISSUE AS EXHIBITING A BLUE TINT CONSISTENT WITH THE COLORING PRESENT ON THE LEADS, AS WELL AS AREAS APPEARING BLACK OR BURNT. THE DISCOLORATION WAS CONFINED TO THE POCKET AND DID NOT EXTEND TO TISSUE ALONG THE LEAD PATHWAY, ANCHORS, OR SPINAL REGION. DURING POSTOPERATIVE DISCUSSION WITH THE SURGEON, IT WAS REPORTED THAT THE PATIENT HAD A PRIOR HISTORY OF TESTICULAR CANCER AND HAD UNDERGONE MULTIPLE MRI SCANS IN THE PAST. THE PHYSICIAN CONFIRMED THAT THE DISCOLORATION APPEARED TO OUTLINE THE SHAPE AND POSITION OF THE COILED LEADS WITHIN THE POCKET AND STATED THAT NO DIAGNOSTIC PROCEDURES INVOLVING DYES OR AGENTS WERE PERFORMED PRIOR TO THE REVISION. THE PHYSICIAN REPORTED THAT ONLY THE TISSUE IN THE POCKET WAS AFFECTED AND NO ABNORMAL DI

  Patient problems: Unspecified Tissue Injury

  MAUDE report 24339793 ↗
• InjuryFeb 12, 2026Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT'S DEVICE WAS REMOVED. ADDITIONAL INFORMATION REGARDING THE NATURE OF THE DEVICE REMOVAL WAS NOT AVAILABLE. THERE WERE NO REPORTS OF DEVICE-RELATED ISSUES PRIOR TO THE DEVICE REMOVAL.

  Patient problems: Insufficient Information

  MAUDE report 24326138 ↗
• InjuryFeb 12, 2026Adverse Event Without Identified Device or Use Problem; Insufficient Device Problem Information

  IT WAS REPORTED THAT THE PATIENT EXPERIENCED PAIN. THE PHYSICIAN BELIEVES THE CONDITION IS RELATED TO THE DEVICE. THE PATIENT UNDERWENT A REVISION PROCEDURE DURING WHICH THE DEVICE WAS REPLACED. THERE HAVE BEEN NO REPORTS OF FURTHER COMPLICATIONS RELATED TO THIS EVENT.

  Patient problems: Pain

  MAUDE report 24324853 ↗
• InjuryJan 23, 2026Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT'S IMPLANTABLE PULSE GENERATOR (IPG) WAS EXPLANTED WHILE THE LEADS WERE LEFT IN SITU. ADDITIONAL INFORMATION REGARDING THE NATURE OF THE DEVICE REMOVAL WAS NOT AVAILABLE. THERE WERE NO REPORTS OF DEVICE-RELATED ISSUES PRIOR TO THE DEVICE REMOVAL.

  Patient problems: Insufficient Information

  MAUDE report 24161898 ↗
• InjuryJan 7, 2026Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT'S DEVICE WAS REMOVED. ADDITIONAL INFORMATION REGARDING THE NATURE OF THE DEVICE REMOVAL WAS NOT AVAILABLE. THERE WERE NO REPORTS OF DEVICE-RELATED ISSUES PRIOR TO THE DEVICE REMOVAL.

  Patient problems: Insufficient Information

  MAUDE report 23991498 ↗
• InjuryDec 30, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT'S DEVICE WAS REMOVED. AN HCP ASSESSMENT REGARDING THE CAUSE OF THE REPORTED EVENT WAS NOT AVAILABLE. THERE WERE NO REPORTS OF DEVICE-RELATED ISSUES PRIOR TO THE DEVICE REMOVAL. THERE HAVE BEEN NO REPORTS OF FURTHER COMPLICATIONS REGARDING THIS EVENT.

  Patient problems: Insufficient Information

  MAUDE report 23928206 ↗
• InjuryDec 30, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT'S DEVICE WAS REMOVED. AN HCP ASSESSMENT REGARDING THE CAUSE OF THE REPORTED EVENT WAS NOT AVAILABLE. THERE WERE NO REPORTS OF DEVICE-RELATED ISSUES PRIOR TO THE DEVICE REMOVAL. THERE HAVE BEEN NO REPORTS OF FURTHER COMPLICATIONS REGARDING THIS EVENT.

  Patient problems: Insufficient Information

  MAUDE report 23924017 ↗
• InjuryDec 23, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT EXPERIENCED SHOCKING SENSATIONS. AN HCP ASSESSMENT REGARDING THE CAUSE OF THE REPORTED EVENT WAS NOT AVAILABLE. THE PATIENT HAD THE DEVICE EXPLANTED. THERE HAVE BEEN NO REPORTS OF FURTHER COMPLICATIONS REGARDING THIS EVENT.

  Patient problems: Pain

  MAUDE report 23883524 ↗
• InjuryDec 23, 2025Adverse Event Without Identified Device or Use Problem; Insufficient Device Problem Information; Adverse Event Without Identified Device or Use Problem; Insufficient Device Problem Information

  IT WAS REPORTED THAT THE PATIENT ACQUIRED A BACTERIAL INFECTION AT THE POCKET SITE AS A POSSIBLE REJECTION. THE PATIENT WAS HOSPITALIZED AND HAD THE DEVICE EXPLANTED. PATIENT EXPERIENCED AN HEMATOMA AS WELL. THERE HAVE BEEN NO REPORTS OF FURTHER COMPLICATIONS REGARDING THIS EVENT.

  Patient problems: Bacterial Infection; Hematoma; Insufficient Information

  MAUDE report 23879849 ↗