GUARDIAN™ 6010 (UDI 05414734403061)Recalls & reported problems
St. Jude Medical, Inc. · Cranial Burr Hole Cover Sys. · Class 2 · Implant
Quick summary
This is the Guardian 6010 cranial burr hole cover, an implanted cap used to seal holes drilled in the skull, often alongside neurostimulator leads. Of 25 reports naming its identifier, most describe infections, wound problems, or tissue erosion at the implant site, often leading to surgical removal; they include 1 death and 22 injuries. No recalls name this device.
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
- 25
- Deaths reported
- 1
- Injuries reported
- 22
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 25 adverse event reports that list this exact device (DI 05414734403061), received between Aug 8, 2017 and Sep 17, 2023 — classified as 1 death, 22 injuries, 2 malfunctions.
The most frequently reported specific device problem is “Mechanical 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
Device problems
- Adverse Event Without Identified Device or Use Problem23
- Mechanical Problem2
- Unstable2
Patient problems
- Unspecified Infection7
- Post Operative Wound Infection6
- Discomfort3
- Inadequate Pain Relief2
- No Clinical Signs, Symptoms or Conditions2
- No Known Impact Or Consequence To Patient2
- Death1
- Erosion1
Recent adverse event reports
The 25 most recent of 25 reports, in the reporter's own words as published by the FDA.
InjurySep 17, 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 THE PATIENT EXPERIENCED AN INFECTION AT THE BURR HOLE CAP. SURGICAL INTERVENTION TOOK PLACE WHEREIN THE BURR HOLE CAP AND LEAD WERE EXPLANTED TO ADDRESS THE ISSUE. IT IS UNKNOWN WHICH BURR HOLE CAP ATTRIBUTED TO THE EVENT.
Patient problems: Unspecified Infection
MAUDE report 17762346 ↗InjuryApr 14, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
RELATED MANUFACTURER REFERENCE NUMBER: 1627487-2021-02163, 1627487-2021-02165, AND 1627487-2021-02166. IT WAS REPORTED THAT THE PATIENT EXPERIENCED DISCOMFORT AT THE IPG AND LEAD SITES. DR. HEBB REVISED THE POCKET MULTIPLE TIMES WITH NO RESOLUTION. AS A RESULT, THE SYSTEM WAS EXPLANTED ON (B)(6) 2021.
Patient problems: Discomfort
MAUDE report 11666160 ↗InjuryJan 11, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
RELATED MANUFACTURER REPORT 1627487-2021-00213; RELATED MANUFACTURER REPORT 1627487-2021-00215. IT WAS REPORTED THAT PATIENT EXPERIENCED A TRAUMA RESULTING IN DEVELOPING A SCAB ON THE BURR HOLE LOCATION RESULTING IN INFLAMMATION AND FESTERING SECRETION. THE LEAD AND THE BURR HOLE COVERS WERE EXPLANTED. NO ADDITIONAL INFORMATION IS AVAILABLE AT THIS TIME.
Patient problems: Inflammation
MAUDE report 11145733 ↗InjuryMay 26, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
ADDITIONAL INFORMATION RECEIVED INDICATES THAT THE INFECTION LATER RESOLVED.
Patient problems: Unspecified Infection
MAUDE report 10088243 ↗InjuryMar 22, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
ADDITIONAL FOLLOW UP INFORMATION FOUND THE PATIENT WAS TREATED WITH ANTIBIOTICS AND NO INFECTION WAS FOUND.
Patient problems: Unspecified Infection
MAUDE report 9863876 ↗InjuryFeb 10, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
IT WAS REPORTED THAT THE LEAD ACCESSORY WAS ERODING THROUGH THE SKIN. AS A RESULT, THE PRODUCT WAS EXPLANTED, AND A NEW ACCESSORY WAS IMPLANTED. THERE WERE NO COMPLICATIONS DURING THE PROCEDURE. PATIENT WAS STABLE.
Patient problems: Erosion
MAUDE report 9688818 ↗InjuryJan 30, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
RELATED MANUFACTURER REFERENCE NUMBER: 1627487-2020-00928; RELATED MANUFACTURER REFERENCE NUMBER: 1627487-2020-00930; RELATED MANUFACTURER REFERENCE NUMBER: 1627487-2020-00931; RELATED MANUFACTURER REFERENCE NUMBER: 1627487-2020-00932; RELATED MANUFACTURER REFERENCE NUMBER: 1627487-2020-00934; RELATED MANUFACTURER REFERENCE NUMBER: 1627487-2020-00935. IT WAS REPORTED THAT THE PATIENT HAD AN INFECTION AT THE IPG AND CRANIAL SITES. AS A RESULT, THE PHYSICIAN ADMINISTERED ANTIBIOTICS PRIOR TO THE PROCEDURE AND REVISED THE INCISION SITES. NO PRODUCT WAS EXPLANTED.
Patient problems: Post Operative Wound Infection
MAUDE report 9646198 ↗InjuryNov 27, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
FURTHER FOLLOW-UP INDICATES THE INFECTION HAS RESOLVED.
Patient problems: Unspecified Infection
MAUDE report 9385978 ↗InjuryNov 12, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
DEVICE 7 OF 7: RELATED MANUFACTURER REFERENCE NUMBER: 1627487-2019-12554. RELATED MANUFACTURER REFERENCE NUMBER: 1627487-2019-12555. RELATED MANUFACTURER REFERENCE NUMBER: 1627487-2019-12556. RELATED MANUFACTURER REFERENCE NUMBER: 1627487-2019-12557. RELATED MANUFACTURER REFERENCE NUMBER: 1627487-2019-12558. RELATED MANUFACTURER REFERENCE NUMBER: 1627487-2019-12559. IT WAS REPORTED THE PATIENT EXPERIENCED AN INFECTION AT AN UNKNOWN LOCATION. TO ADDRESS THE ISSUE, THE PHYSICIAN EXPLANTED THE DBS SYSTEM (EXACT DATE IS UNKNOWN). NO FURTHER DETAILS WERE ABLE TO BE OBTAINED.
Patient problems: Post Operative Wound Infection
MAUDE report 9310209 ↗InjuryNov 12, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
DEVICE 6 OF 7: RELATED MANUFACTURER REFERENCE NUMBER: 1627487-2019-12554. RELATED MANUFACTURER REFERENCE NUMBER: 1627487-2019-12555. RELATED MANUFACTURER REFERENCE NUMBER: 1627487-2019-12556. RELATED MANUFACTURER REFERENCE NUMBER: 1627487-2019-12557. RELATED MANUFACTURER REFERENCE NUMBER: 1627487-2019-12558. RELATED MANUFACTURER REFERENCE NUMBER: 1627487-2019-12560. IT WAS REPORTED THE PATIENT EXPERIENCED AN INFECTION AT AN UNKNOWN LOCATION. TO ADDRESS THE ISSUE, THE PHYSICIAN EXPLANTED THE DBS SYSTEM (EXACT DATE IS UNKNOWN). NO FURTHER DETAILS WERE ABLE TO BE OBTAINED.
Patient problems: Post Operative Wound Infection
MAUDE report 9310204 ↗InjurySep 18, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
IT WAS REPORTED THAT THERE WAS AN INFECTION AT THE BURR HOLE COVER. SURGICAL INTERVENTION TOOK PLACE ON (B)(6) 2019 TO ADDRESS THE ISSUE WHEREIN THE LEAD AND BURR HOLE COVER WERE EXPLANTED. IT IS UNKNOWN WHICH BURR HOLE COVER WAS INVOLVED IN THE EVENT, THEREFORE BOTH WILL BE REPORTED. RELATED MANUFACTURER REFERENCE NUMBER: 1627487-2019-10494. RELATED MANUFACTURER REFERENCE NUMBER: 1627487-2019-10492.
Patient problems: Unspecified Infection
MAUDE report 9084231 ↗InjurySep 18, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
IT WAS REPORTED THAT THERE WAS AN INFECTION AT THE BURR HOLE COVER. SURGICAL INTERVENTION TOOK PLACE ON (B)(6) 2019 TO ADDRESS THE ISSUE WHEREIN THE LEAD AND BURR HOLE COVER WERE EXPLANTED. IT IS UNKNOWN WHICH BURR HOLE COVER WAS INVOLVED IN THE EVENT, THEREFORE BOTH WILL BE REPORTED. RELATED MANUFACTURER REFERENCE NUMBER: 1627487-2019-10491. RELATED MANUFACTURER REFERENCE NUMBER: 1627487-2019-10494.
Patient problems: Unspecified Infection
MAUDE report 9084230 ↗InjuryJun 14, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
RELATED MANUFACTURER REFERENCE# 1627487-2019-06970.
Patient problems: Post Operative Wound Infection
MAUDE report 8702012 ↗InjuryMay 15, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
MFR. REFERENCE REPORT: 1627487-2019-05656. IT WAS REPORTED THAT THE PATIENT'S BURR HOLE CAPS WERE INFUSED WITH TISSUE AND BONE CALCIFICATION. THE BURR HOLE CAP'S JAWS COULD NOT OPEN AND THE INSERT FELL APART. THE BURR HOLE CAPS WERE EXPLANTED AND REPLACED ON (B)(6) 2019.
Patient problems: Discomfort
MAUDE report 8613238 ↗InjuryMay 15, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
MANUFACTURER REFERENCE REPORT: 1627487-2019-05653.
Patient problems: Discomfort
MAUDE report 8613209 ↗DeathApr 10, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
DEVICE 3 OF 4; REFERENCE MFR. REPORT# 1627487-2019-02449, REFERENCE MFR. REPORT# 1627487-2019-02450, REFERENCE MFR. REPORT# 1627487-2019-04278. FOLLOW-UP INFORMATION REVEALED THE PHYSICIAN IMPLANTED AN ADDITIONAL LEAD AND CRANIAL BURR HOLE COVER SYSTEM DURING THE IMPLANT PROCEDURE ON (B)(6) 2019. THE PATIENT'S ADDITIONAL LEAD AND GUARDIAN CRANIAL BURR HOLE COVER SYSTEM HAVE BEEN ADDED TO THIS REPORT AS (DEVICE 3 AND DEVICE 4).
Patient problems: Death
MAUDE report 8500148 ↗InjuryFeb 1, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
DEVICE 3 OF 3: MFR REFERENCE REPORT: 1627487-2018-12113, AND 1627487-2019-01407. IT WAS REPORTED THAT THE PATIENT HAD A HEAD WOUND HEALING ISSUE. THE FULL SYSTEM WAS EXPLANTED ON (B)(6) 2018.
Patient problems: Impaired Healing
MAUDE report 8296567 ↗InjuryNov 30, 2018Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
IT WAS REPORTED THE PATIENT EXPERIENCED DECREASED WOUND HEALING AT THE BURR HOLE COVER SITE. CULTURES WERE TAKEN AND WERE POSITIVE FOR CUTIBACTERIUM. IN TURN, PATIENT WAS GIVEN IV ANTIBIOTICS AND THE PRODUCT WAS EXPLANTED. THE WOUND HAS HEALED.
Patient problems: Unspecified Infection
MAUDE report 8119439 ↗InjuryOct 22, 2018Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
DEVICE 1 OF 2. REFERENCE MDR. REPORT#: 1627487-2018-10336. IT WAS REPORTED DURING A LEAD REVISION PROCEDURE ON (B)(6) 2018, (REFERENCE MFR. REPORT#: 1627487-2018-09633) THE GUARDIAN BURR COVER WAS FOUND TO HAVE "POPPED OUT". AS SUCH, THE PHYSICIAN OPTED TO REPLACE THE DEVICE. IT WAS NOTED THE ORIGINAL GUARDIAN BASE RING WAS LEFT IMPLANTED, ONLY THE LOCKING MECHANISM AND CAP WERE REPLACED. REPORTEDLY, THE PROCEDURE WAS COMPLETED SUCCESSFULLY.
Patient problems: Inadequate Pain Relief
MAUDE report 7990763 ↗InjuryOct 19, 2018Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
DEVICE 2 OF 2. REFERENCE MDR. REPORT#: 1627487-2018-10325. IT WAS REPORTED DURING A LEAD REVISION PROCEDURE ON (B)(6) 2018, (REFERENCE MFR. REPORT#: 1627487-2018-09633) THE GUARDIAN BURR COVER WAS FOUND TO HAVE "POPPED OUT". AS SUCH, THE PHYSICIAN OPTED TO REPLACE THE DEVICE. IT WAS NOTED THE ORIGINAL GUARDIAN BASE RING WAS LEFT IMPLANTED, ONLY THE LOCKING MECHANISM AND CAP WERE REPLACED. REPORTEDLY, THE PROCEDURE WAS COMPLETED SUCCESSFULLY.
Patient problems: Inadequate Pain Relief
MAUDE report 7986887 ↗InjuryAug 31, 2018Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
DEVICE 1 OF 2: REFERENCE MFR. REPORT# 1627487-2018-08212. IT WAS REPORTED DURING AN DBS IMPLANT, THE PATIENT EXPERIENCED WEAKNESS LOCATED IN THEIR RIGHT HAND AND ARM. AS A RESULT THE PHYSICIAN REMOVED THE LEADS. CT SCAN REVEALED THE PATIENT EXPERIENCED A MODEST HEMORRHAGE. THE PATIENT WAS INTUBATED AND ADMINISTERED IN INTENSIVE CARE.
Patient problems: Hemorrhage/Blood Loss/Bleeding; Muscle Weakness/Atrophy
MAUDE report 7838060 ↗InjuryJul 10, 2018Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
DEVICE 7 OF 7: REFERENCE MFR. REPORT #: 1627487-2018-06345; REFERENCE MFR. REPORT #: 1627487-2018-06346; REFERENCE MFR. REPORT #: 1627487-2018-06347; REFERENCE MFR. REPORT #: 1627487-2018-06348; REFERENCE MFR. REPORT #: 1627487-2018-06349; REFERENCE MFR. REPORT #: 1627487-2018-06350. FOLLOW UP INFORMATION IDENTIFIED THE PHYSICIAN ADMITTED THE PATIENT TO THE HOSPITAL AND ADMINISTERED IV ANTIBIOTICS FOR (B)(6). FURTHER INFORMATION REVEALED THE PATIENT WAS RE-ADMITTED TO THE HOSPITAL FOR CONTINUED TREATMENT OF THE ONGOING INFECTION.
Patient problems: Post Operative Wound Infection
MAUDE report 7674918 ↗InjuryJul 10, 2018Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
DEVICE 6 OF 7, REFERENCE MFR. REPORT #: 1627487-2018-06345, REFERENCE MFR. REPORT #: 1627487-2018-06346, REFERENCE MFR. REPORT #: 1627487-2018-06347, REFERENCE MFR. REPORT #: 1627487-2018-06348, REFERENCE MFR. REPORT #: 1627487-2018-06349, REFERENCE MFR. REPORT #: 1627487-2018-06351. FOLLOW UP INFORMATION IDENTIFIED THE PHYSICIAN ADMITTED THE PATIENT TO THE HOSPITAL AND ADMINISTERED IV ANTIBIOTICS FOR (B)(6). FURTHER INFORMATION REVEALED THE PATIENT WAS RE-ADMITTED TO THE HOSPITAL FOR CONTINUED TREATMENT OF THE ONGOING INFECTION.
Patient problems: Post Operative Wound Infection
MAUDE report 7674907 ↗MalfunctionAug 8, 2017Mechanical Problem; Unstable; Unstable
DEVICE 1 OF 2. REFERENCE MFR. REPORT#1627487-2017-04361. IT WAS REPORTED DURING DBS IMPLANT, THE INTRACRANIAL LEAD MIGRATED DUE TO IMPROPER SECURING OF THE LEAD BY THE GUARDIAN BURR HOLE COVER. TROUBLESHOOTING DID NOT PROVIDE RESOLUTION. AS A RESULT, THE PHYSICIAN OPTED TO REPLACE THE BURR HOLE COVER. IN TURN, THE CASE WAS COMPLETED. THERE WAS NO KNOWN PATIENT CONSEQUENCE.
Patient problems: No Clinical Signs, Symptoms or Conditions; No Known Impact Or Consequence To Patient
MAUDE report 6775741 ↗MalfunctionAug 8, 2017Mechanical Problem; Unstable; Unstable
DEVICE 2 OF 2. REFERENCE MFR. REPORT#1627487-2017-04360. IT WAS REPORTED DURING DBS IMPLANT, THE INTRACRANIAL LEAD MIGRATED DUE TO IMPROPER SECURING OF THE LEAD BY THE GUARDIAN BURR HOLE COVER. TROUBLESHOOTING DID NOT PROVIDE RESOLUTION. AS A RESULT, THE PHYSICIAN OPTED TO REPLACE THE BURR HOLE COVER. IN TURN, THE CASE WAS COMPLETED. THERE WAS NO KNOWN PATIENT CONSEQUENCE.
Patient problems: No Clinical Signs, Symptoms or Conditions; No Known Impact Or Consequence To Patient
MAUDE report 6775738 ↗
Other COVER, BURR HOLE devices
- GUARDIAN™ 6010St. Jude Medical, Inc. · COVER, BURR HOLE151 reports
- "1.5MM" SYSTEM 95-1505Biomet Microfixation, Inc · COVER, BURR HOLE23 reports
- "1.5MM" SYSTEM 91-6105Biomet Microfixation, Inc · COVER, BURR HOLE20 reports
- CRANIOFIX® ABSORBABLE FF016Aesculap AG · COVER, BURR HOLE8 reports
- "1.5MM" SYSTEM 91-6106Biomet Microfixation, Inc · COVER, BURR HOLE7 reports
- 1.5MM SYSTEM 91-6105X-50Biomet Microfixation, Inc · COVER, BURR HOLE6 reports
- TMS SYSTEM 25-2007Biomet Microfixation, Inc · COVER, BURR HOLE3 reports
- 1.5MM SYSTEM 01-7114Biomet Microfixation, Inc · COVER, BURR HOLE2 reports
Sources: FDA GUDID, MAUDE and Medical Device Recalls via openFDA. openFDA data is not validated for clinical or regulatory use.