HAKIM PROGRAMMABLE MICRO VALVE
Report
- Report Number
- 1226348-2014-11885
- Event Type
- Injury
- Date Received
- August 12, 2014
- Manufacturer
- CODMAN & SHURTLEFF, INC.
- Product Code
- JXG
- PMA / PMN Number
- PK980778
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- US
- Reporter Occupation
- MEDICAL EQUIPMENT COMPANY TECHNICIAN/REPRESENTATIVE
Narratives
(B)(4). IT HAS BEEN COMMUNICATED THAT THE DEVICE IS NOT AVAILABLE FOR EVALUATION. WITHOUT THE DEVICE IT IS NOT POSSIBLE FOR CODMAN TO CONDUCT A PROPER INVESTIGATION. SINCE A LOT NUMBER HAS BEEN PROVIDED A REVIEW OF THE MANUFACTURING RECORDS WILL BE REVIEWED. WE ANTICIPATE THAT THE EVALUATION WILL REVEAL THAT THE DEVICE CONFORMED TO SPECIFICATIONS PRIOR TO RELEASE. IF ANYTHING OTHERWISE IS FOUND THEN A FOLLOW UP REPORT WILL BE FILED. IF AT SOME POINT THE DEVICE DOES BECOME AVAILABLE, THIS COMPLAINT WILL BE RE-OPENED, EVALUATED AND A FOLLOW UP REPORT WILL BE FILED. TRENDS WILL BE MONITORED FOR THIS AND SIMILAR COMPLAINTS. AT THE PRESENT TIME THIS COMPLAINT IS CONSIDERED CLOSED. DEVICE NOT RETURNED.
NO SAMPLE WAS NOT RETURNED FOR EVALUATION. THE COMPLAINT COULD NOT BE VERIFIED. THE LOT NUMBER FOR THE DEVICE IS CHMBDG; PRODUCT CODE 82-3112. IT WAS NOT POSSIBLE TO INVESTIGATE THE COMPLAINT AS NO SAMPLE WAS RETURNED FOR EVALUATION. IF THE SAMPLE IS RETURNED IN THE FUTURE, THIS COMPLAINT WILL BE RE-OPENED AND EVALUATED. REVIEW OF THE HISTORY DEVICE RECORDS CONFIRMED THE VALVE, PRODUCT CODE 82-3112, WITH LOT NUMBER CHMBDG, CONFORMED TO THE SPECIFICATIONS WHEN RELEASED TO STOCK ON THE 31ST OCTOBER 2007. TRENDS WILL BE MONITORED FOR THIS AND SIMILAR COMPLAINTS. AT THE PRESENT TIME, THIS COMPLAINT IS CONSIDERED CLOSED.
IT WAS NOT POSSIBLE TO INVESTIGATE THE COMPLAINT AS NO SAMPLE WAS RETURNED FOR EVALUATION. HOWEVER THE X-RAY PROVIDED SHOWS THAT THE STATOR WAS DISLODGED FROM THE BASE PLATE. IF THE SAMPLE IS RETURNED IN THE FUTURE, THIS COMPLAINT WILL BE RE-OPENED AND EVALUATED. BASED ON THE RESULTS OF THIS INVESTIGATION NO FURTHER ACTION IS REQUIRED. TRENDS WILL BE MONITORED FOR THIS AND SIMILAR COMPLAINTS. AT THE PRESENT TIME THIS COMPLAINT IS CLOSED.
ADDITIONAL INFORMATION RECEIVED ON 8/21/2014 PERTAINING TO THE 10 COMPLAINTS WITH RESPECT TO THE PENDING QUESTIONS ON MRI SETTINGS AND POSSIBLE CHANGES IN THE MRI PROCEDURES. THE RADIOLOGIST OF THE HOSPITAL CONFIRMED THAT NONE OF THE PATIENTS HAD AN MRI WITH MORE THAN 3 TESLA. THE 10 PATIENTS TREATED IN 5 DIFFERENT MRI MACHINES (3 INTERNALLY, 2 EXTERNALLY).
ROTOR DISLOCATED FROM BASEPLATE; PROGRAMMING OF THE VALVE NOT POSSIBLE. VALVE IS STILL IMPLANTED. DETECTION OF DEFECT BY X-RAY WAS (B)(6) 2014. LAST MRI (B)(6) 2014. 8/5/2014: ADDITIONAL INFORMATION EXPLAINED THEY HAVE NOTICED, THAT MOST DISLOCATIONS HAVE BEEN DETECTED (BY XRAY) RIGHT AFTER AN MRI STUDY. WE HAVE X-RAYS OF ALL VALVES THAT ARE CLAIMED TO HAVE A BROKEN ROTOR. ESPECIALLY CASE (B)(6) IS INTERESTING. WE HAVE AN X-RAY IMAGE RIGHT BEFORE AND AFTER AN MRI STUDY. THE ONE UPFRONT SHOWS THE ROTOR IN THE CORRECT PLACE. THE X-RAY, THAT HAS BEEN DONE RIGHT AFTER THE MRI STUDY SHOWS THE ROTOR DISLOCATED. UNFORTUNATELY, THE QUALITY IS TOO BAD TO SCAN THEM. ALL X-RAYS WILL BE SENT TO (B)(4) PAPER BASED. THE OFFICIAL COMPLAINT FORMS HAVE BEEN UPDATED ACCORDINGLY. 8/8/2014: ALSO REPORTED WAS THAT MRI MAGNETIC SETTING IS 1.5T. NO RELEVANT CHANGE IN MR-PROCEDURES IN THE LAST YEARS. IT WAS EXPLAINED THAT (B)(4).
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 478682 | HAKIM PROGRAMMABLE MICRO VALVE | SHUNT, CENTRAL NERVOUS SYSTEM & COMPS | JXG | CODMAN & SHURTLEFF, INC. | CHMBDG |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Required Intervention |