SYNCHROMED II
Report
- Report Number
- 3004209178-2013-12161
- Event Type
- Injury
- Date Received
- July 23, 2013
- Report Date
- June 28, 2013
- Manufacturer
- MDT PUERTO RICO OPERATIONS CO
- Product Code
- LKK
- PMA / PMN Number
- P860004
- Adverse Event
- Yes
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- MN, US
- Reporter Occupation
- OTHER
Narratives
CONCOMITANT PRODUCTS: PRODUCT ID 8596SC, SERIAL# (B)(4), IMPLANTED: (B)(6) 2010, PRODUCT TYPE CATHETER; PRODUCT ID 8578, LOT# N126907, IMPLANTED: (B)(6) 2008, PRODUCT TYPE ACCESSORY; PRODUCT ID 8709, LOT# J0039991R, IMPLANTED: (B)(6) 2000, PRODUCT TYPE CATHETER. (B)(4).
CONCOMITANT PRODUCTS: PRODUCT ID 8596SC, SERIAL # (B)(4), IMPLANTED: (B)(6) 2010, EXPLANTED: (B)(6) 2013, PRODUCT TYPE CATHETER; PRODUCT ID 8578, LOT # N126907, IMPLANTED: (B)(6) 2008, EXPLANTED: (B)(6) 2013, PRODUCT TYPE ACCESSORY; PRODUCT ID 8709, LOT # J0039991R, IMPLANTED: (B)(6) 2000, EXPLANTED: (B)(6) 2013, PRODUCT TYPE CATHETER. (B)(4). ANALYSIS RESULTS WERE NOT AVAILABLE AS OF THE DATE OF THIS REPORT. A FOLLOW-UP REPORT WILL BE SUBMITTED WHEN ANALYSIS IS COMPLETE.
(B)(4).
(B)(4).
(B)(4).
(B)(4).
ANALYSIS OF THE PUMP REVEALED NO ANOMALIES. ANALYSIS OF THE 8596SC CATHETER NOTED THE CATHETER BODY HAD A USER RELATED HOLE. ANALYSIS OF THE 8709 CATHETER REVEALED THE CATHETER WAS RETURNED IN INCOMPLETE SEGMENTS BUT THESE HAD ACCEPTABLE TESTING. (B)(4).
IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.
(B)(4).
IT WAS LATER REPORTED THAT THE FAILED CATHETER DYE STUDY TOOK PLACE ON (B)(6) 2013. IT WAS CONFIRMED THAT THE CATHETER WAS UNABLE TO BE ASPIRATED. THE CATHETER ISSUE REMAINED UNKNOWN. THE PUMP WAS DUE TO BE REPLACED AND THE REPLACEMENT TOOK PLACE ON (B)(6) 2013 AT WHICH TIME THE CATHETER WAS ALSO REPLACED DUE TO THE FAILED CATHETER DYE STUDY. THE REPORTER STATED THAT WHEN THE DOSE WAS DECREASED THE PATIENT¿S PAIN INCREASED BUT THE NUMBNESS DID NOT DECREASE. THE PATIENT HAD PAIN IN HER LOWER BACK. PATIENT STATUS AT THE TIME OF THE REPORT WAS NO INJURY. IT WAS LATER REPORTED THAT THERE WAS ALSO A POSSIBLE PUMP POCKET REVISION. THE REPORTER STATED ¿POCKET LOOSE, PATIENT HAS LOST WEIGHT.¿
IT WAS REPORTED THAT THE PATIENT HAD EXPERIENCED INTERMITTENT NUMBNESS IN HER LEFT LEG FOR APPROXIMATELY 2 YEARS. THE PATIENT STATED THAT SHE HAD BEEN INFORMING HER DOCTOR OF THE ISSUE FOR THE PAST 2 YEARS AND HAD BEEN IGNORED UNTIL APPROXIMATELY 2-3 WEEKS PRIOR TO THE REPORT WHEN THE DOCTOR DECIDED TO PERFORM A CATHETER DYE STUDY. THE PATIENT STATED THAT THE DYE STUDY ¿FAILED¿ AND THE DOCTOR WAS UNABLE TO PROCEED PAST THE FIRST STEP OF THE STUDY. THE PATIENT INDICATED THAT THE DOCTOR WAS UNABLE TO ASPIRATE CEREBROSPINAL FLUID (CSF). THE DOCTOR TOLD THE PATIENT ¿OH, SOMETHING¿S WRONG WITH YOUR CATHETER, WE¿RE GOING TO HAVE TO DO A SURGERY ON YOU¿. THE PATIENT STATED ¿IT WAS DROPPING SOMEWHERE¿IT WAS BEING PUT IN THE WRONG PLACE¿, REFERRING TO THE DELIVERY OF THE MEDICATION. THE DOCTOR THEN DECREASED THE PATIENT¿S MEDICATION FROM HYDROMORPHONE 0.9MG/DAY TO 0.399MG/DAY AND BUPIVACAINE 7.5MG/DAY TO 3.3MG/DAY. THE FOLLOWING MORNING THE PATIENT WAS IN ¿MAJOR WITHDRAWAL¿. THE PATIENT CALLED THE DOCTOR IN TEARS AND WAS SICK AND NAUSEATED. THE PATIENT WAS THEN PRESCRIBED ORAL OXYCODONE. THE PATIENT STATED THAT SHE WAS DEPENDENT ON ORAL MEDICATIONS AND HER PAIN LEVEL WAS NOT. THE PATIENT¿S PAIN WAS NOT BEING MANAGED BECAUSE THE PUMP WAS TURNED DOWN. HOWEVER, THE PATIENT STATED THAT SINCE THE PUMP WAS TURNED DOWN HER LEG HAD NOT GONE NUMB. THE PATIENT¿S CATHETER REVISION WAS SCHEDULED FOR (B)(6) 2013. ADDITIONAL INFORMATION HAS BEEN REQUESTED BUT WAS NOT AVAILABLE AT THE TIME OF THIS REPORT.
IT WAS ALSO REPORTED THAT THE PUMP WAS REPLACED IN (B)(6) 2013 BECAUSE THE BATTERY WAS DEPLETED. THE PATIENT HADN¿T HEARD FROM THE HEALTHCARE PROVIDER (HCP) AS TO WHY THE PUMP FAILED IN JULY.
ADDITIONAL INFORMATION RECEIVED REPORTED THAT THE CAUSE OF THE EVENT WAS A CATHETER TIP OCCLUSION. ALONG WITH THE CATHETER REPLACEMENT ON (B)(6) 2013, THERE WAS ALSO A REPAIR OF A CEREBROSPINAL FLUID (CSF) LEAK. NO PATIENT HOSPITALIZATION WAS REQUIRED DUE TO THE EVENT. THE PATIENT STATUS WAS STATED AS A NON-SERIOUS INJURY/ILLNESS. THE PATIENT CONTINUED TO HAVE MID AND LOW BACK PAIN. ADDITIONAL INFORMATION COULD NOT BE OBTAINED AT THE TIME OF THE REPORT. SHOULD ADDITIONAL BE RECEIVED A SUPPLEMENTAL REPORT WILL BE FILED.
ADDITIONAL INFORMATION WAS NOTED THAT THE PUMP WAS FLIPPING AND THE PATIENT HAD NO PAIN RELIEF. IT WAS NOTED THAT THE PATIENT WAS DOING "WELL" AS OF (B)(6) 2014 AND THEY WERE RECEIVING EFFECTIVE THERAPY. INFORMATION FROM REGULATORY REPORT NUMBER 3007566237-2013-02921 WILL NOW BE REPORTED IN THIS REGULATORY REPORT. ANY NEW INFORMATION WILL BE REPORTED HERE. PREVIOUSLY REPORTED INFORMATION FROM REGULATORY REPORT NUMBER 3007566237-2013-02921: IT WAS REPORTED THAT THE PUMP "USED TO SLIP AROUND BACKWARDS AND THEY WOULD HAVE TO SLIP IT BACK TO FIND THE PORT". THE PATIENT ALSO STATED "THERE HAVE BEEN PROBLEMS WITH IT THAT THEY HAVE IGNORED". NO PATIENT SYMPTOMS WERE REPORTED. THE MEDICATION DELIVERED BY THE DEVICE SYSTEM AT THAT TIME WAS NOT PROVIDED. ADDITIONAL INFORMATION RECEIVED REPORTED THAT IN (B)(6) 2013 THE PUMP WAS MOVED FROM THE FRONT TO THE BACK. ADDITIONAL INFORMATION RECEIVED REPORTED THAT THE PUMP AND CATHETER WAS THE CAUSE OF THE EVENT. THE EVENT WAS DUE TO PUMP INVERSION AND THE CATHETER ISSUE WAS OCCLUSION. THERE WAS A REVISION OF THE PUMP AND CATHETER ON "(B)(6) 2013." IT WAS NOTED THAT THEY REMOVED OCCLUDED CATHETER, REPAIRED CEREBRAL SPINAL FLUID (CSF) LEAK AND IMPLANTED NEW CATHETER AND PUMP. THE PATIENT DID NOT REQUIRE HOSPITALIZATION.
IT WAS REPORTED THAT THE REPORTER DIDN'T KNOW IF THE HEALTHCARE PROVIDER (HCP) SAID THAT IT BUILT UP SCAR TISSUE AT THE END OF THE CATHETER. THE PATIENT'S LEG WAS GOING NUMB AND SHE COULD NOT USE HER LEG, SO SHE WOULD FALL DOWN.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 342967 | SYNCHROMED II | PUMP, INFUSION, IMPLANTED, PROGRAMMABLE | LKK | MDT PUERTO RICO OPERATIONS CO | 863720 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 00056 YR | Required Intervention |