Swift-Lock™ 1192 (UDI 05415067016621)Recalls & reported problems

Summary

The FDA's MAUDE database contains 20 adverse event reports that list this exact device (DI 05415067016621), received between Jul 27, 2018 and Jan 15, 2025 — classified as 20 injuries.

The most frequently reported specific device problem is “Use of Device Problem” (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 20 most recent of 20 reports, in the reporter's own words as published by the FDA.

• InjuryJan 15, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT WAS EXPERIENCING DISCOMFORT AT THE ANCHOR SITE. AS A RESULT, THE PATIENT UNDERWENT SURGICAL INTERVENTION ON (B)(6) 2024 DURING WHICH THE ANCHOR WAS BURIED DEEPER. PAIN RESOLVED. NOTE: IT IS UNKNOWN WHICH ANCHOR IS RELATED TO THIS ISSUE.

  Patient problems: Implant Pain

  MAUDE report 21159711 ↗
• InjuryAug 26, 2021Use of Device Problem; Use of Device Problem

  RELATED MANUFACTURER REFERENCE NUMBER: 1627487-2021-16604. IT WAS REPORTED THE PHYSICIAN CUT THE ENDS OFF OF BOTH ANCHORS DURING IMPLANT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12374463 ↗
• InjuryAug 26, 2021Use of Device Problem; Use of Device Problem

  RELATED MANUFACTURER REFERENCE NUMBER: 1627487-2021-16605. IT WAS REPORTED THE PHYSICIAN CUT THE ENDS OFF OF BOTH ANCHORS DURING IMPLANT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12374447 ↗
• InjuryNov 18, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  REFERENCE MANUFACTURER NUMBER: 1627487-2020-47972. IT WAS REPORTED THAT THE PATIENT DEVELOPED DISCOMFORT AT THE ANCHOR SITE AFTER LOSING 50 POUNDS. IN TURN, THE PATIENT UNDERWENT SURGICAL INTERVENTION WHEREIN THE SCS ANCHORS WERE EXPLANTED AND REPLACED TO ADDRESS THE ISSUES. NOTE: SINCE IT IS NOT KNOWN WHICH DEVICE CONTRIBUTED TO THE ISSUE, ALL POSSIBLE DEVICES ARE BEING REPORTED ON.

  Patient problems: Discomfort

  MAUDE report 10864113 ↗
• InjuryNov 18, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  REFERENCE MANUFACTURER NUMBER: 1627487-2020-47971. IT WAS REPORTED THAT THE PATIENT DEVELOPED DISCOMFORT AT THE ANCHOR SITE AFTER LOSING 50 POUNDS. IN TURN, THE PATIENT UNDERWENT SURGICAL INTERVENTION WHEREIN THE SCS ANCHORS WERE EXPLANTED AND REPLACED TO ADDRESS THE ISSUES. NOTE: SINCE IT IS NOT KNOWN WHICH DEVICE CONTRIBUTED TO THE ISSUE, ALL POSSIBLE DEVICES ARE BEING REPORTED ON.

  Patient problems: Discomfort

  MAUDE report 10864097 ↗
• InjurySep 17, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  REFERENCE MANUFACTURER NUMBER: 3006705815-2020-31489, 1627487-2020-31630, 1627487-2020-31631, 1627487-2020-31633. IT WAS REPORTED THE PATIENT WAS ADMITTED TO THE HOSPITAL AND DIAGNOSED WITH AN INFECTION AT THE IPG SITE THAT HAD SPREAD TO THE LEADS. THE PHYSICIAN STATED THAT THE PATIENT CUT THEIR FOOT A WEEK AFTER THEIR IPG REPLACEMENT AND THE INFECTION SPREAD UP THEIR FOOT TO THEIR IPG SITE. THE PATIENT WAS PRESCRIBED ANTIBIOTICS AND HOSPITALIZED FOR MULTIPLE NIGHTS. NOTE: SINCE IT IS NOT KNOWN WHICH DEVICE CONTRIBUTED TO THE ISSUE, ALL POSSIBLE DEVICES ARE BEING REPORTED ON.

  Patient problems: Post Operative Wound Infection

  MAUDE report 10550522 ↗
• InjurySep 17, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  REFERENCE MANUFACTURER NUMBER: 3006705815-2020-31489, 1627487-2020-31630, 1627487-2020-31631, 1627487-2020-31632. IT WAS REPORTED THE PATIENT WAS ADMITTED TO THE HOSPITAL AND DIAGNOSED WITH AN INFECTION AT THE IPG SITE THAT HAD SPREAD TO THE LEADS. THE PHYSICIAN STATED THAT THE PATIENT CUT THEIR FOOT A WEEK AFTER THEIR IPG REPLACEMENT AND THE INFECTION SPREAD UP THEIR FOOT TO THEIR IPG SITE. THE PATIENT WAS PRESCRIBED ANTIBIOTICS AND HOSPITALIZED FOR MULTIPLE NIGHTS. NOTE: SINCE IT IS NOT KNOWN WHICH DEVICE CONTRIBUTED TO THE ISSUE, ALL POSSIBLE DEVICES ARE BEING REPORTED ON.

  Patient problems: Post Operative Wound Infection

  MAUDE report 10550510 ↗
• InjuryJun 1, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  RELATED MANUFACTURER REFERENCE NUMBERS: 1627487-2020-02823, 1627487-2020-21240, 1627487-2020-21241, 1627487-2020-21244. IT WAS REPORTED THE PATIENT EXPERIENCED AN INFECTION AT THE IPG AND LEAD SITE. SURGICAL INTERVENTION TOOK PLACE WHEREIN THE SCS SYSTEM WAS EXPLANTED TO ADDRESS THE ISSUE.

  Patient problems: Unspecified Infection

  MAUDE report 10107252 ↗
• InjuryJun 1, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  RELATED MANUFACTURER REFERENCE NUMBERS: 1627487-2020-02823, 1627487-2020-21240, 1627487-2020-21241, 1627487-2020-21245. IT WAS REPORTED THE PATIENT EXPERIENCED AN INFECTION AT THE IPG AND LEAD SITE. SURGICAL INTERVENTION TOOK PLACE WHEREIN THE SCS SYSTEM WAS EXPLANTED TO ADDRESS THE ISSUE.

  Patient problems: Unspecified Infection

  MAUDE report 10107247 ↗
• InjuryMar 11, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  RELATED MANUFACTURER REFERENCE NUMBERS: 3006705815-2020-01127, 1627487-2020-02623, 1627487-2020-02625, 1627487-2020-02627. IT WAS REPORTED THAT THE PATIENT EXPERIENCED INFECTION. IT IS UNKNOWN IF THE INFECTION WAS AT THE LEAD SITE OR IPG SITE. IN TURN, SURGICAL INTERVENTION WAS UNDERTAKEN IN (B)(6) OF 2015 (EXACT DATE UNKNOWN) WHEREIN THE ENTIRE SCS SYSTEM WAS EXPLANTED. NO ADDITIONAL INFORMATION IS AVAILABLE.

  Patient problems: Unspecified Infection

  MAUDE report 9817932 ↗
• InjuryMar 11, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  RELATED MANUFACTURER REFERENCE NUMBERS: 3006705815-2020-01127, 1627487-2020-02623, 1627487-2020-02625, 1627487-2020-02626. IT WAS REPORTED THAT THE PATIENT EXPERIENCED INFECTION. IT IS UNKNOWN IF THE INFECTION WAS AT THE LEAD SITE OR IPG SITE. IN TURN, SURGICAL INTERVENTION WAS UNDERTAKEN IN (B)(6) 2015 (EXACT DATE UNKNOWN) WHEREIN THE ENTIRE SCS SYSTEM WAS EXPLANTED. NO ADDITIONAL INFORMATION IS AVAILABLE.

  Patient problems: Unspecified Infection

  MAUDE report 9817930 ↗
• InjuryOct 4, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  RELATED MANUFACTURER REFERENCE NUMBER: 3006705815-2019-03820, 1627487-2019-11285, 1627487-2019-11286 . IT WAS REPORTED THAT THE PATIENT EXPERIENCED AN INFECTION. AS A RESULT, THE PATIENT'S SYSTEM WAS EXPLANTED IN (B)(6) 2018 (EXACT DATE OF EXPLANT IS UNKNOWN).

  Patient problems: Unspecified Infection

  MAUDE report 9158150 ↗
• InjuryFeb 28, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  DEVICE 4 OF 5. REFERENCE MFR. REPORT#: 3006705815-2019-00758. REFERENCE MFR. REPORT#:1627487-2019-02813. REFERENCE MFR. REPORT#:1627487-2019-02814. REFERENCE MFR. REPORT#:1627487-2019-02816.

  Patient problems: Unspecified Infection

  MAUDE report 8378481 ↗
• InjuryFeb 27, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  DEVICE 5 OF 5 REFERENCE MFR. REPORT#: 3006705815-2019-00758; REFERENCE MFR. REPORT#:1627487-2019-02813; REFERENCE MFR. REPORT#:1627487-2019-02814; REFERENCE MFR. REPORT#:1627487-2019-02815.

  Patient problems: Unspecified Infection

  MAUDE report 8374234 ↗
• InjuryNov 8, 2018Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  DEVICE 1 OF 2. REFERENCE MFR REPORT: 1627487-2018-11781. IT WAS REPORTED THE PATIENT EXPERIENCED PAIN AT THE SCS LEAD ANCHOR IMPLANT SITE. REPORTEDLY, THE PATIENT REPORTED TENDERNESS AT THE LUMBAR SCS ANCHOR SURGICAL INCISION. SURGICAL INTERVENTION MAY BE TAKEN TO ADDRESS THE ISSUE.

  Patient problems: Irritation; Pain

  MAUDE report 8053854 ↗
• InjuryNov 8, 2018Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  DEVICE 2 OF 2 REFERENCE MFR REPORT: 1627487-2018-11780. IT WAS REPORTED THE PATIENT EXPERIENCED PAIN AT THE SCS LEAD ANCHOR IMPLANT SITE. REPORTEDLY, THE PATIENT REPORTED TENDERNESS AT THE LUMBAR SCS ANCHOR SURGICAL INCISION. SURGICAL INTERVENTION MAY BE TAKEN TO ADDRESS THE ISSUE.

  Patient problems: Irritation; Pain

  MAUDE report 8053850 ↗
• InjuryOct 1, 2018Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  DEVICE 4 OF 4. REFERENCE MFR. REPORT: 1627487-2018-09360, REFERENCE MFR. REPORT: 1627487-2018-09361, REFERENCE MFR. REPORT: 1627487-2018-09438. IT WAS REPORTED THE PATIENT DEVELOPED AN INFECTION AT THE LEAD SITE. THE PATIENT IS CURRENTLY AT THE HOSPITAL FOR UNRELATED HEALTH ISSUES.

  Patient problems: Unspecified Infection

  MAUDE report 7924289 ↗
• InjuryOct 1, 2018Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  DEVICE 3 OF 4. REFERENCE MFR. REPORT: 1627487-2018-09360, REFERENCE MFR. REPORT: 1627487-2018-09361, REFERENCE MFR. REPORT: 1627487-2018-09439. IT WAS REPORTED THE PATIENT DEVELOPED AN INFECTION AT THE LEAD SITE. THE PATIENT IS CURRENTLY AT THE HOSPITAL FOR UNRELATED HEALTH ISSUES.

  Patient problems: Unspecified Infection

  MAUDE report 7924287 ↗
• InjuryAug 21, 2018Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  DEVICE 5 OF 5: REFERENCE MFR. REPORT #: 1627487-2018-07763, REFERENCE MFR. REPORT #: 1627487-2018-07764, REFERENCE MFR. REPORT #: 3006705815-2018-01965, REFERENCE MFR. REPORT #: 1627487-2018-07765. IT WAS REPORTED THE PATIENT EXPERIENCED PAIN AROUND THE MIDLINE INCISION. THE PHYSICIAN FELT IT WAS A POSSIBLE INFECTION AT THE IPG AND LEAD SITE AND PRESCRIBED ANTIBIOTICS FOR THE PATIENT. THE PATIENT¿S SYMPTOMS DID NOT RESOLVE, THEREFORE THE PHYSICIAN EXPLANTED THE SCS SYSTEM. A CULTURE WAS OBTAINED, BUT THE RESULTS ARE NOT KNOWN AT THIS TIME.

  Patient problems: Post Operative Wound Infection

  MAUDE report 7801081 ↗
• InjuryJul 27, 2018Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  DEVICE 4 OF 4. REFERENCE MFR REPORT#1627487-2018-07009. REFERENCE MFR REPORT#1627487-2018-07001. REFERENCE MFR REPORT#1627487-2018-06959. IT WAS REPORTED AN INFECTION WAS SUSPECTED AT THE PATIENT'S SUPRA-ORBITAL LEAD SITE. HOWEVER, ANTIBIOTICS WERE NOT PRESCRIBED AS TREATMENT. FOLLOW-UP IDENTIFIED THE ISSUE IS RESOLVING ON ITS OWN WITHOUT INTERVENTION.

  Patient problems: Unspecified Infection

  MAUDE report 7728140 ↗