SYNCHROMED II
Report
- Report Number
- 3004209178-2013-11297
- Event Type
- Death
- Date Received
- July 3, 2013
- Date of Event
- April 16, 2013
- Report Date
- June 12, 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
- PHYSICIAN
Narratives
(B)(4). ANALYSIS OF THE CATHETER SERIAL # (B)(4) INITIALLY REVEALED AN OCCLUSION. THE OCCLUSION WAS ABLE TO BE BROKEN LOOSE AND WAS NOT RELATED TO THE MANUFACTURE OF THE CATHETER. NEITHER CATHETER HAD AN EVIDENCE OF HAVING BEEN COMPRESSED AN NO ANOMALIES WERE SEEN WITH THE METAL PORTION OF THE SUTURE.
CONCOMITANT PRODUCTS: PRODUCT ID 8598A, SERIAL # (B)(4), EXPLANTED: (B)(6) 2013, PRODUCT TYPE CATHETER. (B)(4).
PRODUCT ID: 8598A LOT# SERIAL# (B)(4), IMPLANTED: 2013 (B)(6), PRODUCT TYPE CATHETER PRODUCT ID: 8596SC LOT# SERIAL# (B)(4), IMPLANTED: 2013 (B)(6), EXPLANTED: 2013 (B)(6), PRODUCT TYPE CATHETER PRODUCT ID: 8835 LOT# SERIAL# (B)(4), PRODUCT TYPE PROGRAMMER, PATIENT. (B)(4) .
ANALYSIS OF THE PUMP REVEALED NO ANOMALY FOUND. ANALYSIS OF THE CATHETER 8596SC, LOT # H877502909 NO ANOMALY FOUND. ANALYSIS OF THE CATHETER 8595A, LOT # H856701012, NO SIGNIFICANT ANOMALY CATHETER MISCELLANEOUS ACCEPTABLE TESTING CATHETER INCOMPLETE RETURNED IN SEGMENTS.
CONCOMITANT MEDICAL PRODUCTS: PRODUCT ID: 8598A, SERIAL# (B)(4), IMPLANTED: (B)(6) 2013, PRODUCT TYPE: CATHETER. PRODUCT ID: 85 96SC, SERIAL# (B)(4), IMPLANTED: (B)(6) 2013, EXPLANTED: (B)(6) 2013, PRODUCT TYPE: CATHETER. PRODUCT ID: 8835, SERIAL# (B)(4), PRODUCT TYPE: PROGRAMMER, PATIENT. PRODUCT ID: 8598A, SERIAL# (B)(4), IMPLANTED: (B)(6) 2013, PRODUCT TYPE: CATHETER. PRODUCT ID: 8596SC, SERIAL# (B)(4), IMPLANTED: (B)(6) 2013, EXPLANTED: (B)(6) 2013, PRODUCT TYPE: CATHETER. THE CATHETER WAS INCOMPLETE, RETURNED IN SEGMENTS. FINAL ANALYSIS OF THE CATHETER REVEALED NO ANOMALY FOUND.
IT WAS REPORTED THAT THE PATIENT HAD A SUDDEN DEATH OF UNDETERMINED ETIOLOGY. IT WAS REPORTEDLY NOT RELATED TO THE IMPLANT PROCEDURE AND WAS UNLIKELY RELATED TO THE DEVICE OR THERAPY. THE DEVICE SYSTEM WAS USED TO DELIVER DILAUDID AND BUPIVACAINE. IT WAS LATER REPORTED THAT AN AUTOPSY REPORTED WAS NOT EXPECTED. IT WAS LATER REPORTED THAT THE PATIENT WAS SEEN BY THE IMPLANT REGISTERED NURSE (RN) ON MONDAY AND SHE WAS DOING FINE. THEY HAD JUST STARTED TITRATING THE PATIENT¿S NEW PUMP MEDICATIONS UP. THE PATIENT WAS ON DILAUDID 0.1MG/DAY AND IT WAS INCREASED TO 0.3MG/DAY. THE PATIENT WAS DOING GREAT MONDAY EVENING. IT WAS NOTED THAT THE PATIENT WAS A ¿NIGHT OWL¿, WENT OUT SHOPPING, RETURNED HOME AT 4:30AM AND WENT TO BED. THE PATIENT¿S HUSBAND CHECKED ON HER DURING THE DAY AND SHE WAS DOING FINE. LATER IN THE EVENING, THE HE FOUND THE PATIENT DECEASED. THE RN CHECKED TO SEE IF SHE PROGRAMMED THE PUMP FOR 3MG/DAY INSTEAD OF 0.3MG/DAY. IT WAS NOTED THAT THE PATIENT¿S HUSBAND DID NOT BELIEVE THE PATIENT¿S DEATH WAS DEVICE-RELATED. IT WAS LATER REPORTED THAT THE DATE OF DEATH WAS (B)(6) 2013. IT WAS UNKNOWN IF THE DEATH WAS DEVICE RELATED. IT WAS LATER CONFIRMED THAT A DOSE CHANGE TO 0.3MG/DAY OF DILAUDID WAS DONE ON (B)(6) 2013. AT THIS TIME, THE DEVICE SYSTEM WAS ALSO USED TO DELIVER BUPIVACAINE 3.160MG/DAY. NO CONCENTRATION CHANGES WERE DONE.
ADDITIONAL INFORMATION RECEIVED REPORTED 1 WEEK POST OP THE PATIENT WAS INCREASED FROM MINIMUM FLOW RATE TO LOWEST FLOW RATE, THEN 1 WEEK AFTER THAT, THE PATIENT WAS DECREASED BACK TO MIN FLOW RATE DUE TO SEVERE EDEMA. THE PATIENT HAD SINCE BEEN LEFT AT THAT RATE. PER THE TELEMETRY REPORTS PROVIDED, THE PATIENT MEDICATION BEING DELIVERED VIA THE PUMP POST CATHETER REVISION WAS DILAUDID AND BUPIVICAINE. IT WAS LATER REPORTED THAT THE CATHETER HAD BEEN FOUND TO BE OCCLUDED DUE TO BEING PRESSED AGAINST PATIENT TISSUE AND THE METAL CLIP ON THE SUTURELESS CONNECTOR APPEARED BENT. IT WAS UNKNOWN WHICH OF THOSE TWO CAUSED THE ADVERSE EVENT. THE PATIENT REPORTED HAVING NO PAIN CONTROL. DURING THE REVISION, THE CATHETER TIP WAS ALSO MOVED TO T9. THE PATIENT OUTCOME WAS REPORTED AS RESOLVED WITHOUT SEQUELAE. ADDITIONAL INFORMATION RECEIVED REPORTED THE EVENT DATE WAS BEING UPDATED TO (B)(6) 2013.
IT WAS FURTHER REPORTED THAT THE PATIENT EXPERIENCED NO PAIN CONTROL AND LOSS OF PAIN CONTROL AND THE METAL CLIPS ON THE SUTURELESS CONNECTOR APPEARED BENT. THE ISSUE WAS RESOLVED WITHOUT SEQUELAE ON (B)(6) 2013 AS A SURGICAL INTERVENTION TOOK PLACE AND IT WAS OBSERVED THAT THE METAL CLIPS APPEARED BENT AND THE CATHETER WAS SPLICED. THIS WAS REPORTED AS RELATED TO THE DEVICE OR THERAPY BUT NOT RELATED TO THE IMPLANT PROCEDURE. THIS SYSTEM HAD DELIVERED FENTANYL, DILAUDID, AND BUPIVACAINE PRIOR TO THE REVISION. ALTHOUGH IT WAS PREVIOUSLY REPORTED THAT THE CATHETER WAS OCCLUDED DUE TO BEING PRESSED AGAINST PATIENT TISSUE; THE METAL CLIP ON SUTURELESS CONNECTOR APPEARED BENT; AND IT WAS UNKNOWN WHICH OF THESE TWO CAUSED THE ADVERSE EVENT. IT WAS NOW REPORTED THAT THE CATHETER WAS OCCLUDED DUE TO BEING PRESSED AGAINST PATIENT TISSUE. IT WAS ALSO PREVIOUSLY REPORTED THAT THE SURGICAL OBSERVATION AND DIAGNOSTIC RESULTS WERE THE METAL CLIPS APPEARED BENT AND THE INABILITY TO ASPIRATE FLUID ON (B)(6) 2013. IT WAS NOW ONLY REPORTED AS THE INABILITY TO ASPIRATE FLUID ON (B)(6) 2013.
A REPRESENTATIVE REPORTED THAT THE PATIENT AS GOING TO HAVE A CATHETER REVISION. THE DATE WAS NOT DETERMINED AT THE TIME OF THE REPORT. THE PATIENT DID NOT TOLERATE THE FENTANYL. THEY HAD SEVERE ITCHING EVEN AT THE LOWEST DOSE. THEY FURTHER STATED THEIR CHRONIC PAIN WAS NOT BEING MANAGED. THE PATIENT WAS SWITCHED TO HYDROMORPHONE ON THE DAY OF THE REPORT. THEY PLANNED TO GO INTO THE SIDE PORT TO ASPIRATE ALL OF THE FENTANYL OUT OF THE CATHETER AND INNER TUBING. THEY WERE NOT ABLE TO ASPIRATE. THE PATIENT WAS PROGRAMMED WITH THE NEW DRUG AT MINIMUM FLOW RATE, BUT AT THE TIME OF THE SURGERY, THE PATIENT WILL STILL HAVE THE OLD DRUG IN THE INNER PUMP TUBING AND CATHETER. THEY STATED ¿IT WAS CRITICAL THAT THE PUMP BE PRIMED AFTER THE CATHETER IS DISCONNECTED WITH 0.199 ML BEFORE THE CATHETER WAS RECONNECTED TO THE PUMP AGAIN. A CATHETER REVISION WAS PLANNED FOR (B)(6) 2013. IT WAS LATER REPORTED THAT THE REVISION SURGERY WAS COMPLETED ON (B)(6) 2013. CEREBROSPINAL FLUID (CSF) FLOW FROM THE SPINAL SEGMENT WAS OBTAINED. THE PUMP WAS DISCONNECTED AND A BACK TABLE PRIME WAS COMPLETED. A NEW 8596SC WAS ATTACHED, AND CSF FLOW WAS OBTAINED FROM THE COMPLETE SYSTEM. THE CATHETER WAS RECONNECTED TO THE PUMP, AND THE SYSTEM WAS FUNCTIONING PROPERLY.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 305592 | SYNCHROMED II | PUMP, INFUSION, IMPLANTED, PROGRAMMABLE | LKK | MDT PUERTO RICO OPERATIONS CO | 8637-40 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 00055 YR | Death| R |