Swift-Lock™ 1192 (UDI 05414734400671)Recalls & reported problems

Summary

The FDA's MAUDE database contains 215 adverse event reports that list this exact device (DI 05414734400671), received between Jun 15, 2018 and Jun 16, 2026 — classified as 215 injuries.

The most frequently reported specific device problem is “Fracture” (10 reports).

1 other recall cover devices cleared under the same FDA submission (K092371); they may or may not involve this specific model.

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 25 most recent of 215 reports, in the reporter's own words as published by the FDA.

• InjuryJun 16, 2026Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THE PATIENT EXPERIENCED PAIN AT THE ANCHOR SITE. SURGICAL INTERVENTION TOOK PLACE ON (B)(6) 2026 WHEREIN THE ANCHOR WAS REPOSITIONED TO ADDRESS THE ISSUE.

  Patient problems: Implant Pain

  MAUDE report 25524108 ↗
• InjurySep 4, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT PATIENT EXPERIENCED AN INFECTION AT THE IPG AND LEAD SITES. AS A RESULT, SURGICAL INTERVENTION WAS UNDERTAKEN ON (B)(6) 2025 WHEREIN THE ENTIRE SYSTEM WAS EXPLANTED TO ADDRESS THE ISSUE. THE PATIENT WAS ADMINISTERED ANTIBIOTICS TO ADDRESS THE ISSUE.

  Patient problems: Post Operative Wound Infection

  MAUDE report 22974174 ↗
• InjurySep 4, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT PATIENT EXPERIENCED AN INFECTION AT THE IPG AND LEAD SITES. AS A RESULT, SURGICAL INTERVENTION WAS UNDERTAKEN ON (B)(6) 2025 WHEREIN THE ENTIRE SYSTEM WAS EXPLANTED TO ADDRESS THE ISSUE. THE PATIENT WAS ADMINISTERED ANTIBIOTICS TO ADDRESS THE ISSUE.

  Patient problems: Post Operative Wound Infection

  MAUDE report 22973658 ↗
• InjuryAug 6, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT PATIENT EXPERIENCED AN INFECTION AT THE IPG AND LEAD SITE. AS A RESULT, SURGICAL INTERVENTION WAS UNDERTAKEN WHEREIN THE ENTIRE SYSTEM WAS EXPLANTED TO ADDRESS THE ISSUE. THE INFECTION HAS RESOLVED.

  Patient problems: Unspecified Infection

  MAUDE report 22730293 ↗
• InjuryAug 6, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT PATIENT EXPERIENCED AN INFECTION AT THE IPG AND LEAD SITE. AS A RESULT, SURGICAL INTERVENTION WAS UNDERTAKEN WHEREIN THE ENTIRE SYSTEM WAS EXPLANTED TO ADDRESS THE ISSUE. THE INFECTION HAS RESOLVED.

  Patient problems: Unspecified Infection

  MAUDE report 22730287 ↗
• InjuryOct 3, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT PATIENT EXPERIENCED AN INFECTION AT THE LEAD AND IPG SITE. SURGICAL INTERVENTION WAS UNDERTAKEN WHEREIN THE SYSTEM WAS EXPLANTED TO ADDRESS THIS ISSUE.TAKEN WHEREIN THE SYSTEM WAS EXPLANTED TO ADDRESS THIS ISSUE.

  Patient problems: Unspecified Infection

  MAUDE report 20364438 ↗
• InjurySep 18, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT HAD AN INFECTION AT THE IPG & LEAD SITES. AS A RESULT, THE ENTIRE SYSTEM WAS EXPLANTED VIA SURGICAL INTERVENTION ON (B)(6) 2024. THE PATIENT WAS GIVEN ORAL ANTIBIOTICS TO ADDRESS THE ISSUE.

  Patient problems: Unspecified Infection

  MAUDE report 20248900 ↗
• InjurySep 18, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT HAD AN INFECTION AT THE IPG & LEAD SITES. AS A RESULT, THE ENTIRE SYSTEM WAS EXPLANTED VIA SURGICAL INTERVENTION ON (B)(6) 2024. THE PATIENT WAS GIVEN ORAL ANTIBIOTICS TO ADDRESS THE ISSUE.

  Patient problems: Unspecified Infection

  MAUDE report 20248552 ↗
• InjuryJul 8, 2024Migration; Migration

  ADDITIONAL INFORMATION RECEIVED REPORTS THAT THE PATIENT UNDERWENT SURGICAL INTERVENTION ON (B)(6) 2024 IN WHICH THEIR LEADS AND ANCHORS WERE EXPLANTED AND REPLACED.

  Patient problems: Inadequate Pain Relief

  MAUDE report 19694923 ↗
• InjuryJul 8, 2024Migration; Migration

  ADDITIONAL INFORMATION RECEIVED REPORTS THAT THE PATIENT UNDERWENT SURGICAL INTERVENTION ON (B)(6) 2024 IN WHICH THEIR LEADS AND ANCHORS WERE EXPLANTED AND REPLACED.

  Patient problems: Inadequate Pain Relief

  MAUDE report 19694543 ↗
• InjuryJun 28, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THE PATIENT WAS EXPERIENCING DISCOMFORT AT THE LEADS AND ANCHORS SITES. SURGICAL INTERVENTION TOOK PLACE ON (B)(6) 2024 WHEREIN BOTH LEADS AND ANCHORS WERE PLACED DEEPER IN THE POCKET SITE TO ADDRESS THE ISSUE. DISCOMFORT HAS RESOLVED.

  Patient problems: Implant Pain

  MAUDE report 19634958 ↗
• InjuryJun 28, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THE PATIENT WAS EXPERIENCING DISCOMFORT AT THE LEADS AND ANCHORS SITES. SURGICAL INTERVENTION TOOK PLACE ON (B)(6) 2024 WHEREIN BOTH LEADS AND ANCHORS WERE PLACED DEEPER IN THE POCKET SITE TO ADDRESS THE ISSUE. DISCOMFORT HAS RESOLVED.

  Patient problems: Implant Pain

  MAUDE report 19634194 ↗
• InjuryMay 7, 2024Fracture; Fracture

  IT WAS REPORTED THAT THE PATIENT'S LEADS HAD MIGRATED AND ONE OF THE LEADS AND ANCHOR WERE FRACTURED. THE INVESTIGATION DID NOT DETERMINE WHICH ANCHOR ATTRIBUTED TO THE ISSUE. SURGICAL INTERVENTION WAS UNDERTAKEN, AND THE LEADS AND ANCHOR WERE EXPLANTED AND REPLACED.

  Patient problems: Failure of Implant

  MAUDE report 19265135 ↗
• InjurySep 18, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  RELATED MANUFACTURER REPORT NUMBER: 3006705815-2023-05810. IT WAS REPORTED THAT THE PATIENT WAS EXPERIENCING IRRITATION AT THE SITE OF THE SCS LEAD ANCHOR. SURGICAL INTERVENTION WAS UNDERTAKEN ON (B)(6) 2023 WHEREIN THE PATIENT'S SCS LEAD ANCHOR WAS BURIED DEEPER AND FLATTER TO ADDRESS THE ISSUE. ADDITIONALLY, DURING THE MENTIONED REVISION THE PHYSICIAN NOTED A SPARK AND A LOSS OF WIRELESS CONNECTION TO THE IPG WHILE CAUTERIZATION WAS TAKING PLACE. TROUBLESHOOTING WAS ATTEMPTED DURING THE PROCEDURE AND THE IPG WAS SUCCESSFULLY RECONNECTED. THERAPY WAS RESTORED POST OPERATIVELY.

  Patient problems: Implant Pain

  MAUDE report 17768865 ↗
• InjurySep 1, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED PATIENT HAD A LEAD POCKET REVISION BECAUSE THE ANCHOR WAS NOT COMFORTABLE WITH THE ORIGINAL PLACEMENT. INVESTIGATION WAS UNABLE TO DETERMINE WHICH OF THE ANCHOR ATTRIBUTED TO THE EVENT. THE ANCHOR WAS REPOSITIONED, AND SAME LEADS WERE USED.

  Patient problems: Implant Pain

  MAUDE report 17674754 ↗
• InjuryAug 9, 2023Fracture; Fracture

  RELATED MANUFACTURER REFERENCE NUMBER: 3006705815-2023-04373, 3006705815-2023-04978. IT WAS REPORTED THE PATIENT EXPERIENCED INEFFECTIVE STIMULATION DUE TO ONE LEAD BEING FRACTURED, ONE LEAD MIGRATING AND ONE ANCHOR WAS FRACTURED. SURGICAL INTERVENTION TOOK PLACE WHEREIN THE ENTIRE SYSTEM WAS EXPLANTED AND REPLACED. THERAPY WAS RESTORED. IPG WAS ELECTIVELY REPLACED.

  Patient problems: Inadequate Pain Relief

  MAUDE report 17495538 ↗
• InjuryAug 5, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT EXPERIENCED PAIN AT THE ANCHOR SITE. AS A RESULT, SURGICAL INTERVENTION WAS UNDERTAKEN ON (B)(6) 2023 WHEREIN THE ANCHOR WAS EXPLANTED AND REPLACED TO ADDRESS THE ISSUE.

  Patient problems: Implant Pain

  MAUDE report 17467109 ↗
• InjuryJun 5, 2023Material Fragmentation; Material Fragmentation

  IT WAS REPORTED THAT DURING A LEAD REVISION PROCEDURE, THE PHYSICIAN HAD DIFFICULTY REMOVING THE SWIFT LOCK ANCHOR DUE TO SCAR TISSUE. AS SUCH, THE SWIFT LOCK ANCHOR BROKE AND WAS UNABLE TO BE REMOVED. A PORTION OF THE PLASTIC TIP OF THE ANCHORS REMAINS IMPLANTED IN THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17066158 ↗
• InjuryMay 11, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  RELATED MANUFACTURER REFERENCE NUMBER: 3006705815-2023-02822, 1627487-2023-02117. IT WAS REPORTED THE PATIENT WAS ADMITTED TO THE HOSPITAL AND DIAGNOSED WITH AN SEPSIS AT THE LEAD SITE. THE PATIENT WAS HOSPITALIZED AND HAD THE SCS SYSTEM EXPLANTED TO ADDRESS THE ISSUE.

  Patient problems: Sepsis

  MAUDE report 16911129 ↗
• InjuryMay 8, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  RELATED MANUFACTURER REPORT NUMBER 1627487-2023-02143. IT WAS REPORTED THAT PATIENT IS COMPLAINING OF PAIN AT THE MIDLINE INCISION AND ANCHOR SITE. THE PATIENT UNDERWENT SURGICAL INTERVENTION WHEREIN THE ANCHORS WERE EXPLANTED AND REPLACED TO ADDRESS THE ISSUE.

  Patient problems: Implant Pain

  MAUDE report 16892098 ↗
• InjuryMay 8, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  RELATED MANUFACTURER REPORT NUMBER 1627487-2023-02018. IT WAS REPORTED THAT PATIENT IS COMPLAINING OF PAIN AT THE MIDLINE INCISION AND ANCHOR SITE. THE PATIENT UNDERWENT SURGICAL INTERVENTION WHEREIN THE ANCHORS WERE EXPLANTED AND REPLACED TO ADDRESS THE ISSUE.

  Patient problems: Implant Pain

  MAUDE report 16892074 ↗
• InjuryMay 1, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT WAS EXPERIENCING SWELLING FROM THEIR DRG IMPLANT. SURGICAL INTERVENTION OCCURRED WHERE THE ANCHORS WERE EXPLANTED TO ADDRESS THE ISSUE.

  Patient problems: Swelling/ Edema

  MAUDE report 16842995 ↗
• InjuryApr 25, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  PER THE ADDITIONAL INFORMATION RECEIVED, THE DEVICE DID NOT CONTRIBUTE TO REPORTED ISSUE, THERE IS NO DEVICE MALFUNCTION. HENCE, THIS DEVICE NO LONGER MEETS THE REPORTABILITY CRITERIA.

  Patient problems: Implant Pain

  MAUDE report 16811323 ↗
• InjuryApr 21, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  RELATED MANUFACTURER REPORT NUMBER 3006705815-2023-02439 AND 1627487-2023-01858 IT WAS REPORTED PATIENT HAD AN INFECTION AT BOTH INCISION SITE, LEAD AND IPG SITE. THE PATIENT'S SCS SYSTEM WAS EXPLANTED ON (B)(6) 2023.

  Patient problems: Post Operative Wound Infection

  MAUDE report 16786086 ↗
• InjuryMar 30, 2023Material Fragmentation; Material Fragmentation

  RELATED MANUFACTURER REPORT NUMBER: 1627487-2022-03537, 1627487-2022-03539. IT WAS REPORTED THAT THE PATIENT LOSS THERAPY DUE TO HIGH IMPEDANCES ON BOTH LEADS. IT WAS NOTED THAT THE PATIENT HAD A FALL. AS A RESULT, THE PATIENT UNDERWENT SURGICAL INTERVENTION TO ADDRESS THE ISSUE. DURING THE PROCEDURE, IT WAS NOTED THAT ONE OF THE ANCHORS HAD BROKEN INTO 2 PIECES. IN TURN, THE LEADS AND ANCHOR WERE EXPLANTED AND REPLACED. EFFECTIVE THERAPY WAS ESTABLISHED POST-OPERATIVELY.

  Patient problems: Inadequate Pain Relief

  MAUDE report 16641136 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K092371. One submission often covers many models, so check the product and lot details in each record.

• Z-1425-2010 · Feb 22, 2010 · Terminated
  Swift-Lock (TM) Anchor Accessory Kit, Directions For Use Model 1192, ANS, A St. Jude Medical Company. Product is intended to be used as an accessory to the leads component of ANS