Cinch™ 1194 (UDI 05414734400688)Recalls & reported problems
St. Jude Medical, Inc. · Class 2
Quick summary
This St. Jude Medical Cinch 1194 is an implanted peripheral nerve stimulator, a device placed under the skin to send mild pulses for pain relief. Most of the 29 reports describe infection at the implant or lead sites, sometimes along with wound infection, skin irritation or erosion, and in several cases the whole system had to be surgically removed; one report describes a fracture. There are 29 injuries and no deaths. No recalls name this device, and reports dropped from 2 to 0 in the past 12 months.
AI-generated from the FDA records on this page and checked automatically against the numbers below. Read the details before relying on it.
- Adverse event reports
- 29
- Deaths reported
- 0
- Injuries reported
- 29
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 29 adverse event reports that list this exact device (DI 05414734400688), received between Jul 13, 2018 and Mar 17, 2025 — classified as 29 injuries.
The most frequently reported specific device problem is “Fracture” (1 report).
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.
Reports received per month
Most reported problems
Device problems
- Adverse Event Without Identified Device or Use Problem28
- Fracture1
Patient problems
- Unspecified Infection20
- Post Operative Wound Infection4
- Discomfort2
- Erosion1
- No Consequences Or Impact To Patient1
- Pain1
- Skin Irritation1
Recent adverse event reports
The 25 most recent of 29 reports, in the reporter's own words as published by the FDA.
InjuryMar 17, 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.
Patient problems: Post Operative Wound Infection
MAUDE report 21623866 ↗InjuryMar 17, 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.
Patient problems: Post Operative Wound Infection
MAUDE report 21623670 ↗InjuryDec 27, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
RELATED MANUFACTURER REFERENCE NUMBER: (B)(4). IT WAS REPORTED THAT THE PATIENT RECENTLY LOST WEIGHT, THEIR ANCHORS WERE POKING OUT, AND LEAD HAD HIGH IMPEDANCES. SURGICAL INTERVENTION MAY BE UNDERTAKEN AT A LATER DATE TO ADDRESS THE ISSUE.
Patient problems: Erosion
MAUDE report 18399062 ↗InjuryOct 19, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
RELATED MANUFACTURER REFERENCE NUMBER: 3006705815-2021-05019, 3006705815-2021-05022, 3006705815-2021-05024, 1627487-2021-17613, 1627487-2021-17615, 1627487-2021-17617. IT WAS REPORTED THE PATIENT EXPERIENCED AN INFECTION. SURGICAL INTERVENTION TOOK PLACE WHEREIN THE SYSTEM WAS EXPLANTED. INFECTION WAS TREATED WITH REGULAR AB PROPHYLAXIS DURING SURGERY, PLUS EXTRA RINSING WITH CEFAZOLIN DURING IPG IMPLANT PLUS 5 DAYS OF 600 MG CLINDAMYCIN 3DD. THIS WAS PROLONGED, LATER SWITCHED TO FLOXAPEN.
Patient problems: Unspecified Infection
MAUDE report 12657409 ↗InjuryOct 19, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
RELATED MANUFACTURER REFERENCE NUMBER: 3006705815-2021-05019, 3006705815-2021-05022, 3006705815-2021-05024, 1627487-2021-17613, 1627487-2021-17614, 1627487-2021-17617. IT WAS REPORTED THE PATIENT EXPERIENCED AN INFECTION. SURGICAL INTERVENTION TOOK PLACE WHEREIN THE SYSTEM WAS EXPLANTED. INFECTION WAS TREATED WITH REGULAR AB PROPHYLAXIS DURING SURGERY, PLUS EXTRA RINSING WITH CEFAZOLIN DURING IPG IMPLANT PLUS 5 DAYS OF 600MG CLINDAMYCIN 3DD. THIS WAS PROLONGED, LATER SWITCHED TO FLOXAPEN.
Patient problems: Unspecified Infection
MAUDE report 12657398 ↗InjuryOct 19, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
RELATED MANUFACTURER REFERENCE NUMBER: 3006705815-2021-05019, 3006705815-2021-05022, 3006705815-2021-05024, 1627487-2021-17613, 1627487-2021-17614, 1627487-2021-17615. IT WAS REPORTED THE PATIENT EXPERIENCED AN INFECTION. SURGICAL INTERVENTION TOOK PLACE WHEREIN THE SYSTEM WAS EXPLANTED. INFECTION WAS TREATED WITH REGULAR AB PROPHYLAXIS DURING SURGERY, PLUS EXTRA RINSING WITH CEFAZOLIN DURING IPG IMPLANT PLUS 5 DAYS OF 600MG CLINDAMYCIN 3DD. THIS WAS PROLONGED, LATER SWITCHED TO FLOXAPEN.
Patient problems: Unspecified Infection
MAUDE report 12657379 ↗InjuryOct 19, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
RELATED MANUFACTURER REFERENCE NUMBER: 3006705815-2021-05019, 3006705815-2021-05022, 3006705815-2021-05024, 1627487-2021-17614, 1627487-2021-17615, 1627487-2021-17617. IT WAS REPORTED THE PATIENT EXPERIENCED AN INFECTION. SURGICAL INTERVENTION TOOK PLACE WHEREIN THE SYSTEM WAS EXPLANTED. INFECTION WAS TREATED WITH REGULAR AB PROPHYLAXIS DURING SURGERY, PLUS EXTRA RINSING WITH CEFAZOLIN DURING IPG IMPLANT PLUS 5 DAYS OF 600MG CLINDAMYCIN 3DD. THIS WAS PROLONGED, LATER SWITCHED TO FLOXAPEN.
Patient problems: Unspecified Infection
MAUDE report 12657364 ↗InjuryJul 23, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
RELATED MANUFACTURER REFERENCE NUMBER 1627487-2020-23142. RELATED MANUFACTURER REFERENCE NUMBER 1627487-2020-23144. RELATED MANUFACTURER REFERENCE NUMBER 1627487-2020-23147. IT WAS REPORTED THAT PATIENT UNDERWENT SURGERY (B)(6) 2014 TO HAVE SPINAL CORD STIMULATOR SYSTEM EXPLANTED DUE TO INFECTION. PATIENT IS STABLE.
Patient problems: Unspecified Infection
MAUDE report 10314123 ↗InjuryJul 23, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
RELATED MANUFACTURER REFERENCE NUMBER 1627487-2020-23142. RELATED MANUFACTURER REFERENCE NUMBER 1627487-2020-23144. RELATED MANUFACTURER REFERENCE NUMBER 1627487-2020-23145. IT WAS REPORTED THAT PATIENT UNDERWENT SURGERY (B)(6) 2014 TO HAVE SPINAL CORD STIMULATOR SYSTEM EXPLANTED DUE TO INFECTION. PATIENT IS STABLE.
Patient problems: Unspecified Infection
MAUDE report 10314083 ↗InjuryJun 9, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
MANUFACTURER REPORT NUMBERS: 1627487-2020-21469, 1627487-2020-21471,1627487-2020-21473. IT WAS REPORTED PATIENT'S SCS SYSTEM WAS EXPLANTED DUE TO INFECTION AT AN UNKNOWN PLACE AND UNKNOWN TIME.
Patient problems: Unspecified Infection
MAUDE report 10134061 ↗InjuryMay 1, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
RELATED MANUFACTURER REFERENCE NUMBER: 1627487-2020-04338, RELATED MANUFACTURER REFERENCE NUMBER: 1627487-2020-04339, RELATED MANUFACTURER REFERENCE NUMBER: 1627487-2020-04340, RELATED MANUFACTURER REFERENCE NUMBER: 1627487-2020-04341, RELATED MANUFACTURER REFERENCE NUMBER: 1627487-2020-04343, RELATED MANUFACTURER REFERENCE NUMBER: 1627487-2020-04344, RELATED MANUFACTURER REFERENCE NUMBER: 1627487-2020-04345, RELATED MANUFACTURER REFERENCE NUMBER: 1627487-2020-04346. IT WAS REPORTED THAT THE PATIENTS SYSTEM WAS EXPLANTED ON AND UNKNOWN DATE DUE TO INFECTION. PATIENT DECLINED TO PROVIDE FURTHER INFORMATION.
Patient problems: Unspecified Infection
MAUDE report 10017656 ↗InjuryMay 1, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
RELATED MANUFACTURER REFERENCE NUMBER: 1627487-2020-04338. RELATED MANUFACTURER REFERENCE NUMBER: 1627487-2020-04339. RELATED MANUFACTURER REFERENCE NUMBER: 1627487-2020-04340. RELATED MANUFACTURER REFERENCE NUMBER: 1627487-2020-04341. RELATED MANUFACTURER REFERENCE NUMBER: 1627487-2020-04342. RELATED MANUFACTURER REFERENCE NUMBER: 1627487-2020-04344. RELATED MANUFACTURER REFERENCE NUMBER: 1627487-2020-04345. RELATED MANUFACTURER REFERENCE NUMBER: 1627487-2020-04346. IT WAS REPORTED THAT THE PATIENTS SYSTEM WAS EXPLANTED ON AND UNKNOWN DATE DUE TO INFECTION. PATIENT DECLINED TO PROVIDE FURTHER INFORMATION.
Patient problems: Unspecified Infection
MAUDE report 10017655 ↗InjuryApr 14, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
DEVICE 6 OF 6. REFERENCE MFR. REPORT#: 1627487-2020-03919. REFERENCE MFR. REPORT#: 1627487-2020-03920. REFERENCE MFR. REPORT#: 1627487-2020-03921. REFERENCE MFR. REPORT#: 1627487-2020-03922. REFERENCE MFR. REPORT#: 1627487-2020-03923. IT WAS REPORTED THE PATIENT'S SCS SYSTEM WAS EXPLANTED DUE TO INFECTION AT THE PATIENT'S IPG AND LEAD SITES. THE INFECTION RESOLVED OVER TIME VIA ANTIBIOTIC INTRAVENOUS THERAPY.
Patient problems: Post Operative Wound Infection
MAUDE report 9960006 ↗InjuryApr 14, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
DEVICE 5 OF 6. REFERENCE MFR. REPORT#: 1627487-2020-03919. REFERENCE MFR. REPORT#: 1627487-2020-03920. REFERENCE MFR. REPORT#: 1627487-2020-03921. REFERENCE MFR. REPORT#: 1627487-2020-03922. REFERENCE MFR. REPORT#: 1627487-2020-03924. IT WAS REPORTED THE PATIENT'S SCS SYSTEM WAS EXPLANTED DUE TO INFECTION AT THE PATIENT'S IPG AND LEAD SITES. THE INFECTION RESOLVED OVER TIME VIA ANTIBIOTIC INTRAVENOUS THERAPY.
Patient problems: Post Operative Wound Infection
MAUDE report 9960001 ↗InjuryApr 3, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
RELATED MANUFACTURER REFERENCE# 1627487-2020-03622, 1627487-2020-03620, 1627487-2020-03618, & 1627487-2020-03619. IT WAS REPORTED THE PATIENT¿S ENTIRE SCS SYSTEM WAS REMOVED DUE TO AN INFECTION. THE SITE OF THE INFECTION IS UNKNOWN. THE INFECTION WAS RESOLVED.
Patient problems: Unspecified Infection
MAUDE report 9925313 ↗InjuryApr 3, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
RELATED MANUFACTURER REFERENCE# 1627487-2020-03621, 1627487-2020-03620, 1627487-2020-03618, & 1627487-2020-03619. IT WAS REPORTED THE PATIENT¿S ENTIRE SCS SYSTEM WAS REMOVED DUE TO AN INFECTION. THE SITE OF THE INFECTION IS UNKNOWN. THE INFECTION WAS RESOLVED.
Patient problems: Unspecified Infection
MAUDE report 9925310 ↗InjuryMar 31, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
RELATED MANUFACTURER REFERENCE NUMBER: 1627487-2020-03417, 1627487-2020-03418, 1627487-2020-03419, 1627487-2020-03420. IT WAS REPORTED THE PATIENT HAD AN INFECTION. IN TURN, SURGICAL INTERVENTION WAS UNDERTAKEN ON AN UNKNOWN DATE WHEREIN THE ENTIRE SYSTEM WAS EXPLANTED TO ADDRESS THE ISSUE. REPORTEDLY, THE ISSUE RESOLVED.
Patient problems: Unspecified Infection
MAUDE report 9902797 ↗InjuryMar 31, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
RELATED MANUFACTURER REFERENCE NUMBER: 1627487-2020-03417, 1627487-2020-03418, 1627487-2020-03419, 1627487-2020-03421. IT WAS REPORTED THE PATIENT HAD AN INFECTION. IN TURN, SURGICAL INTERVENTION WAS UNDERTAKEN ON AN UNKNOWN DATE WHEREIN THE ENTIRE SYSTEM WAS EXPLANTED TO ADDRESS THE ISSUE. REPORTEDLY, THE ISSUE RESOLVED.
Patient problems: Unspecified Infection
MAUDE report 9902793 ↗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, 1627487-2019-11284, 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 9158151 ↗InjurySep 25, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
RELATED MANUFACTURER REFERENCE# 3006705815-2019-03672, 1627487-2019-10861 AND 1627487-2019-10862. IT WAS REPORTED THE PATIENT¿S ENTIRE SCS SYSTEM WAS REMOVED DUE TO AN INFECTION. THE SITE OF THE INFECTION AND EXACT DATE OF EXPLANT IS UNKNOWN. NO FURTHER INFORMATION IS AVAILABLE AT THIS TIME.
Patient problems: Unspecified Infection
MAUDE report 9120666 ↗InjurySep 25, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
RELATED MANUFACTURER REFERENCE # 3006705815-2019-03672, 1627487-2019-10861 & 1627487-2019-10863. IT WAS REPORTED THE PATIENT¿S ENTIRE SCS SYSTEM WAS REMOVED DUE TO AN INFECTION. THE SITE OF THE INFECTION AND EXACT DATE OF EXPLANT IS UNKNOWN. NO FURTHER INFORMATION IS AVAILABLE AT THIS TIME.
Patient problems: Unspecified Infection
MAUDE report 9120654 ↗InjuryAug 16, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
RELATED MANUFACTURER REPORT NUMBERS 1627487-2019-09333, 1627487-2019-09334, 1627487-2019-09335. IT WAS REPORTED THAT THE PATIENT HAD AN INFECTION AT AN UNKNOWN DATE. IN TURN, SURGICAL INTERVENTION WAS UNDERTAKEN WHEREIN THE SYSTEM WAS EXPLANTED. FURTHER INFORMATION IS CURRENTLY NOT AVAILABLE.
Patient problems: Unspecified Infection
MAUDE report 8901624 ↗InjuryAug 16, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
RELATED MANUFACTURER REPORT NUMBERS: 1627487-2019-09333, 1627487-2019-09334, 1627487-2019-09336. IT WAS REPORTED THAT THE PATIENT HAD AN INFECTION AT AN UNKNOWN DATE. IN TURN, SURGICAL INTERVENTION WAS UNDERTAKEN WHEREIN THE SYSTEM WAS EXPLANTED. FURTHER INFORMATION IS CURRENTLY NOT AVAILABLE.
Patient problems: Unspecified Infection
MAUDE report 8901619 ↗InjuryMay 8, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
MANUFACTURER REPORT NUMBER 1627487-2019-05485. IT WAS REPORTED THAT THE PATIENT EXPERIENCED DISCOMFORT AT THE ANCHOR SITE WHICH OCCURS WHILE THE PATIENT IS AT CERTAIN POSITIONS. THE LEAD OF THE TAIL WAS CAUSING THE PATIENT DISCOMFORT. THERE WERE NO MALFUNCTION ALLEGATIONS ON THE LEAD. LEAD REVISION WAS COMPLETED ON (B)(6) 2019 WHERE THE TAIL OF THE LEADS WAS SUTURED DOWN DEEPER AT THE LEAD INCISION SITE. PATIENT¿S DISCOMFORT ISSUE WAS RESOLVED WITH THE REVISION PROCEDURE. THERE WERE NO COMPLICATIONS DURING THE SURGERY. PATIENT WAS STABLE.
Patient problems: Discomfort
MAUDE report 8592809 ↗InjuryMay 8, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
MANUFACTURER REPORT NUMBER 1627487-2019-05486. IT WAS REPORTED THAT THE PATIENT EXPERIENCED DISCOMFORT AT THE ANCHOR SITE WHICH OCCURS WHILE THE PATIENT IS AT CERTAIN POSITIONS. THE LEAD OF THE TAIL WAS CAUSING THE PATIENT DISCOMFORT. THERE WERE NO MALFUNCTION ALLEGATIONS ON THE LEAD. LEAD REVISION WAS COMPLETED ON (B)(6) 2019 WHERE THE TAIL OF THE LEADS WAS SUTURED DOWN DEEPER AT THE LEAD INCISION SITE. PATIENT¿S DISCOMFORT ISSUE WAS RESOLVED WITH THE REVISION PROCEDURE. THERE WERE NO COMPLICATIONS DURING THE SURGERY. PATIENT WAS STABLE.
Patient problems: Discomfort
MAUDE report 8592797 ↗
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Sources: FDA GUDID, MAUDE and Medical Device Recalls via openFDA. openFDA data is not validated for clinical or regulatory use.