HAKIM PROGRAMMABLE VALVE
Report
- Report Number
- 3013886523-2025-00069
- Event Type
- Death
- Date Received
- April 4, 2025
- Report Date
- June 25, 2025
- Manufacturer
- INTEGRA LIFESCIENCES MANSFIELD
- Product Code
- JXG
- PMA / PMN Number
- K221840
- Adverse Event
- Yes
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Occupation
- PHYSICIAN
- Health Professional
- Yes
Narratives
UPDATED FIELDS: D9, G3, G6, H2, H3, H6, H11. THE HAKIM VALVE (UNKNOWN ID) WAS NOT RETURNED FOR EVALUATION AFTER THREE GOOD FAITH ATTEMPTS (GFES) WERE MADE. LOT NUMBER INFORMATION HAS NOT BEEN PROVIDED; THEREFORE, AN EVALUATION OF THE DEVICE COULD NOT BE PERFORMED, AND DEVICE HISTORY RECORD (DHR) COULD NOT BE REVIEWED. THE ROOT CAUSE(S) OF THE REPORTED ISSUE COULD NOT BE DETERMINED. IF ADDITIONAL RELEVANT INFORMATION BECOMES AVAILABLE IN THE FUTURE, THIS COMPLAINT WILL BE REOPENED, AND THE RESPECTIVE EVALUATION PERFORMED. TRENDS WILL BE MONITORED FOR THIS AND SIMILAR ISSUES. AT PRESENT, WE CONSIDER THIS COMPLAINT TO BE CLOSED. A MEDICAL ASSESSMENT WAS REQUESTED TO INTEGRA'S MEDICAL SAFETY TEAM: "THERE IS NO INDICATION THAT THE DEVICES MALFUNCTIONED BUT DO SUGGEST THAT PROCEDURAL DEVIATIONS FROM RECOMMENDED INSTRUCTIONS MAY HAVE CONTRIBUTED TO THE EVENTS, AS DEVICES WERE NOT USED AND MONITORED IN ACCORDANCE WITH ALL INSTRUCTIONS INCLUDED IN THE INSTRUCTIONS FOR USE (IFU). THE INFORMATION GATHERED DOES SUGGEST USE ERROR ONLY. IT APPEARS PROGRAMMING WAS PERFORMED BY UNTRAINED RESIDENTS WHO MAY NOT HAVE POSITIONED THE TRANSMITTER PROPERLY ON THE VALVE NOR RESTRICTED MOVEMENT OF THE COIL DURING PROGRAMING, OR OBSERVED THE PROPER OPERATING TEMPERATURE OF THE PROGRAMMER. ADDITIONALLY, THEY DID NOT TAKE CONFORMATIONAL RADIOGRAPHS POST-PROGRAMMING NOR PRE-PROGRAMMING CONFIRM THE SETTING AND IDENTIFY IF THERE HAD BEEN ANY CHANGE OF VALVE SETTING DUE TO STRONG MAGNETIC FORCE. THE HOSPITAL DOES NOT USE EVDÍS ROUTINELY DURING STABILIZATION OF THEIR TRAUMA PATIENTS BUT INSTEAD USE SHUNTS WHERE FIBRIN CLOTS MAY FORM AND DISRUPT VALVE PROGRAMMING. AS PER A CONFERENCE CALL WITH DR. (B)(6) MEDICAL ADVISOR DR. (B)(6). ON (B)(6) 2025, DR. (B)(6) GROUP WILL BE MEETING WITH DR.(B)(6). TO DISCUSS TRAINING, AND CONFIRM ANY ADDITIONAL COMPLAINTS THAT MAY HAVE OCCURRED AND SHOULD BE REPORTED TO INTEGRA."
AN INVESTIGATION HAS BEEN INITIATED BASED ON THE REPORTED INFORMATION. UPON COMPLETION OF THE INVESTIGATION, A FOLLOW-UP REPORT WILL BE SUBMITTED.
UPDATED FIELDS: D9, G3, G6, H2, H3, H11. A MEDICAL ASSESSMENT WAS PROVIDED BY INTEGRA'S MEDICAL AFFAIRS DIRECTOR AS A RESULT OF A CONVERSATION WITH THE FACILITY PHYSICIAN: "THE EVENTS, AS DESCRIBED BY DR. (B)(6), DO NOT IDENTIFY NOR DO THEY INDICATE A CAUSAL EFFECT FROM THE CODMAN HAKIM PROGRAMMABLE VALVES. THERE IS NO INDICATION THAT THE DEVICES MALFUNCTIONED BUT DO SUGGEST THAT PROCEDURAL DEVIATIONS FROM RECOMMENDED INSTRUCTIONS MAY HAVE CONTRIBUTED TO THE EVENTS, AS DEVICES WERE NOT USED AND MONITORED IN ACCORDANCE WITH ALL INSTRUCTIONS INCLUDED IN THE INSTRUCTIONS FOR USE (IFU). THE INFORMATION GATHERED DOES SUGGEST USE ERROR ONLY. IT APPEARS PROGRAMMING WAS PERFORMED BY UNTRAINED RESIDENTS WHO MAY NOT HAVE POSITIONED THE TRANSMITTER PROPERLY ON THE VALVE NOR RESTRICTED MOVEMENT OF THE COIL DURING PROGRAMING, OR OBSERVED THE PROPER OPERATING TEMPERATURE OF THE PROGRAMMER. ADDITIONALLY, THEY DID NOT TAKE CONFORMATIONAL RADIOGRAPHS POST-PROGRAMMING NOR PRE-PROGRAMMING CONFIRM THE SETTING AND IDENTIFY IF THERE HAD BEEN ANY CHANGE OF VALVE SETTING DUE TO STRONG MAGNETIC FORCE. THE HOSPITAL DOES NOT USE EVD S ROUTINELY DURING STABILIZATION OF THEIR TRAUMA PATIENTS BUT INSTEAD USE SHUNTS WHERE FIBRIN CLOTS MAY FORM AND DISRUPT VALVE PROGRAMMING. AS PER A CONFERENCE CALL WITH DR. (B)(6) MEDICAL ADVISOR, DR. (B)(6) GROUP WILL BE MEETING WITH THE PHYSICIAN TO DISCUSS TRAINING, AND CONFIRM ANY ADDITIONAL COMPLAINTS THAT MAY HAVE OCCURRED AND SHOULD BE REPORTED TO INTEGRA."
N/A
THIS IS 1 OF 2 REPORTS LINKED TO MFG REPORT NUMBERS: 3013886523-2025-00068. A PHYSICIAN REPORTED: ON AN UNSPECIFIED DATE, A CODMAN HAKIM PROGRAMMABLE VALVE (CHPV) WAS IMPLANTED FOR AN UNREPORTED INDICATION. ON AN UNKNOWN DATE, THE PATIENT HAD INEFFICIENCY MANAGING THE CSF (CEREBROSPINAL FLUID) FLOW. THE PATIENT TRAGICALLY PASSED AWAY ON AN UNKNOWN DATE LAST YEAR DUE TO VENTRICULAR COLLAPSE, WHICH WAS ATTRIBUTED TO THE VALVE'S PERFORMANCE BY THE PHYSICIAN. IT WAS UNKNOWN IF AN AUTOPSY WAS PERFORMED. NO PATIENT INFORMATION PROVIDED INCLUDING: AGE, GENDER, CONCURRENT CONDITION, FAMILY HISTORY PAST MEDICATION, CONCOMITANT MEDICATION AND CO-SUSPECT MEDICATIONS, DRUG ALLERGIES. NO ADDITIONAL INFORMATION HAS BEEN PROVIDED AFTER SEVERAL ATTEMPTS.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1048711 | HAKIM PROGRAMMABLE VALVE | CHPV | JXG | INTEGRA LIFESCIENCES MANSFIELD |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | NA | Unknown | Death |