Craniectomy Template Kit CT-01-KRecalls & reported problems
Neuropace, Inc. · The Craniectomy Template package contains 1 Craniectomy Template, 1 Lead Strain Relief and 1 Torque Driver. · Class 3 · Implant
Data updated Oct 16, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 1
- Deaths reported
- 0
- Injuries reported
- 1
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 00855547005380), received between Jul 10, 2024 and Jul 10, 2024 — classified as 1 injury.
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.
Reports received per month
Most reported problems
Device problems
- Adverse Event Without Identified Device or Use Problem1
Patient problems
- Intracranial Hemorrhage1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
InjuryJul 10, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
DURING AN INITIAL IMPLANT OF THE RNS SYSTEM (RNS NEUROSTIMULATOR AND TWO LEADS), TWO BURR HOLES WERE DRILLED AND TWO DEPTH ELECTRODES WERE IMPLANTED (BILATERAL MTL LEADS). DURING THE CRANIECTOMY PORTION OF THE SURGERY FOR THE NEUROSTIMULATOR, THE PATIENT EXPERIENCED EXCESSIVE BLOOD LOSS AND CONCOMITANT HYPOTENSION. THE BLOOD LOSS APPEARED TO COME PRIMARILY FROM THE SITE OF THE FERRULE CRANIECTOMY. THE PATIENT'S CONDITION WAS SEVERE ENOUGH THAT IT REQUIRED THE NEUROSTIMULATOR IMPLANT TO BE ABORTED AND FOR THE PATIENT TO RECEIVE SEVERAL UNITS OF BLOOD. THE PATIENT HAD HER CRANIECTOMY SITE PACKED WITH GEL FOAM TO STOP THE BLEEDING AFTER WHICH ALL INCISIONS WERE ULTIMATELY CLOSED, WITH GEL FOAM PACKED IN PLACE. WHEN THE BLEEDING HAD APPARENTLY STOPPED AND HER VITALS RE-NORMALIZED, THE PATIENT WAS STABILIZED AND TRANSFERRED TO THE ICU FOR CT/IMAGING/OBSERVATION.
Patient problems: Intracranial Hemorrhage
MAUDE report 19713533 ↗
Other Implanted brain stimulator for epilepsy devices
- RNS® Neurostimulator Kit RNS-320-KNeuropace, Inc. · Implanted brain stimulator for epilepsy2 deaths218 reports
- RNS® Neurostimulator Kit RNS-320-KNeuropace, Inc. · Implanted brain stimulator for epilepsy108 reports
- RNS® Neurostimulator Kit RNS-300M-KNeuropace, Inc. · Implanted brain stimulator for epilepsy105 reports
- NeuroPace® Depth Lead Kit DL-330-10-KNeuropace, Inc. · Implanted brain stimulator for epilepsy30 reports
- NeuroPace® Depth Lead Kit DL-344-10-KNeuropace, Inc. · Implanted brain stimulator for epilepsy26 reports
- NeuroPace® Depth Lead Kit DL-344-10-KNeuropace, Inc. · Implanted brain stimulator for epilepsy23 reports
- NeuroPace® Depth Lead Kit DL-330-10-KNeuropace, Inc. · Implanted brain stimulator for epilepsy22 reports
- NeuroPace® Depth Lead Kit DL-330-3.5-KNeuropace, Inc. · Implanted brain stimulator for epilepsy21 reports
Sources and updates
- Device record: FDA GUDID, file dated Oct 13, 2026 · View this device in AccessGUDID ↗
- Adverse event reports: FDA MAUDE, file dated Oct 14, 2026 · each report above links to its original FDA record
- Recalls: FDA Medical Device Recalls, file dated Oct 16, 2026
- Page last rebuilt: Oct 16, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
How reports and recalls are matched · Editorial policy · Report an error on this page