SYNCHROMED II
Report
- Report Number
- 3004209178-2014-09309
- Event Type
- Injury
- Date Received
- May 20, 2014
- Report Date
- August 4, 2016
- Manufacturer
- MEDTRONIC PUERTO RICO OPERATIONS CO.
- Product Code
- LKK
- PMA / PMN Number
- P860004
- Adverse Event
- Yes
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- TX, US
- Reporter Occupation
- PHYSICIAN
Narratives
ANALYSIS OF THE PUMP SERIAL NUMBER (B)(4) FOUND NO ANOMALY. PUMP DISPENSE ACCURACY PASSED. ANALYSIS OF THE CATHETER SERIAL NUMBER (B)(4) FOUND SC CONNECTOR NON-SIGNIFICANT INDENT IN SEAL, DID NOT AFFECT INFUSION.
CONCOMITANT MEDICAL PRODUCTS: PRODUCT ID: 8731SC, SERIAL# (B)(4), IMPLANTED: (B)(6) 2008, PRODUCT TYPE: CATHETER. (B)(4).
(B)(4).
A GOOD FAITH EFFORT WILL BE MADE TO OBTAIN THE APPLICABLE INFORMATION RELEVANT TO THE REPORT. IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.
(B)(4).
CONCOMITANT MEDICAL PRODUCTS: PRODUCT ID 8731SC, SERIAL# (B)(4), IMPLANTED: (B)(6) 2008, EXPLANTED: (B)(6) 2014. (B)(4).
ADDITIONAL INFORMATION RECEIVED REPORTED IT WAS NOT BELIEVED THAT ANYTHING WAS DONE TO THE EXISTING PUMP. A FOLLOW-UP REPORT WILL BE SENT IF ADDITIONAL INFORMATION BECOMES AVAILABLE.
ADDITIONAL INFORMATION WAS RECEIVED FROM A CONSUMER AND IT WAS REPORTED THAT THE PUMP FAILED AND PUT THE PATIENT INTO BACLOFEN WITHDRAWAL.
ADDITIONAL INFORMATION RECEIVED REPORTED THE PATIENT WAS HOSPITALIZED AND IT WAS UNKNOWN WHAT THE PRODUCT ISSUE WAS. IT WAS NOTED THE PATIENT WAS ADMITTED TO THE HOSPITAL FOR UNDERDOSE SYMPTOMS INCLUDING ITCHING AND INCREASED SPASTICITY AND THE PATIENT'S MOTHER DID NOT WANT TO GIVE HER DAUGHTER ORAL MEDICATION. NOTHING WAS NOTED IN THE LOGS AND THE PATIENT'S STATUS AT THE TIME OF THIS REPORT WAS "ALIVE-NO INJURY." IT WAS FURTHER REPORTED THE PATIENT HAD BEEN EXPERIENCING WITHDRAWAL EPISODES SPORADICALLY AND TWO PREVIOUS DYE STUDIES CONFIRMED THE CATHETERS WERE PATENT. IT WAS REPORTED THE PATIENT WAS HAVING SIGNS OF WITHDRAWAL AND OVERDOSE IN PARTICULAR SPASTICITY. IT WAS NOTED SHE HAD SPASTICITY THAT WAS EXAGGERATED ONE DAY AND THEN SHE WAS FLACCID THE NEXT. IT WAS REPORTED EVERYTHING STARTED (B)(6) 2014. A DYE STUDY WAS PERFORMED ON (B)(6) 2014 AND THE CATHETER ASPIRATED WELL AND DYE WAS SEEN ON FLUOROSCOPY AND FLOWED FREELY. THE ROLLER STUDY WAS SUCCESSFUL AND THE VENTRICULO-PERITONEAL (VP) SHUNT WAS CHECKED AND IT WAS FUNCTIONING WITH NO PROBLEMS. ON (B)(6) 2014 THE DOCTOR PLANNED TO REPLACE BOTH THE PUMP AND THE CATHETER. EXPOSURE OF THE PUMP SITE CONFIRMED CATHETER CONNECTION AT THE PUMP WAS SECURE. THE DOCTOR ALSO STATED HE SAW CEREBROSPINAL FLUID (CSF) FLOW AT THE CATHETER SITE IN THE SPINE AFTER DISCONNECTING THE PUMP AND CATHETER SEGMENT. IN CONCLUSION THE DOCTOR DID NOT SEE ANY PRODUCT ISSUES THAT WOULD EXPLAIN THE PATIENT'S SYMPTOMS. IT WAS DECIDED TO NOT REPLACE THE CATHETER AT THIS TIME AND THE PATIENT WAS GIVE SOME ZANAFLEX AND WAS "DOING GREAT." IT WAS ALSO REPORTED SINCE THE PATIENT RECEIVED THE NEWLY IMPLANTED SYSTEM THE PATIENT WAS "DOING FINE."
IT WAS REPORTED THE PATIENT WAS EXPERIENCING WITHDRAWAL SYMPTOMS. IT WAS REPORTED THE PATIENT WAS BROUGHT TO THE ER AND WAS HOSPITALIZED ¿AS OF FRIDAY.¿ THE PUMP WAS USED TO DELIVER LIORESAL. IT WAS REPORTED THE CATHETER WAS DRAINED DURING REPLACEMENT AND THE ¿PRINT OUT¿ WAS PROGRAMMED CORRECTLY. IT WAS NOTED THERE WAS AN UNKNOWN CATHETER ISSUE. IT WAS REPORTED THERE WAS INCREASED SPASTICITY AND UNDERDOSE SYMPTOMS. IT WAS REPORTED THE PATIENT WAS HOME WITH THEIR MOTHER. IT WAS REPORTED THE PATIENT WAS EXHIBITING: CLONUS, COULD NOT WALK, VERY STIFF LEGS, THE NECK PULLED TIGHT ON ONE SIDE, AND THEY ¿COULD NOT LIFT THEIR NECK.¿ IT WAS NOTED THE PATIENT URINATED ON THEMSELVES WHICH WAS UNUSUAL. IT WAS NOTED THERE WAS CONFUSION AND THEY WERE FORGETFUL. ADDITIONAL INFORMATION REPORTED THE PATIENT¿S ITCHING WAS GONE AND THE PATIENT WAS NO LONGER ON ORALS. IT WAS STATED THE PATIENT¿S FEET WERE TIGHT AND TURNING IN. IT WAS NOTED THE PATIENT WAS HAVING TROUBLE RECOGNIZING PEOPLE THEY NORMALLY KNEW. IT WAS STATED THE PATIENT WAS HAVING SWEATY EPISODES AND BODY TWITCHING. IT WAS NOTED THERE WAS NO SPASTICITY IN THE LEGS. IT WAS NOTED THE HEALTH CARE PROVIDER (HCP) WAS PERPLEXED AND THEY WERE UNCERTAIN IF ALL THE SYMPTOMS WERE PUMP RELATED. ADDITIONAL INFORMATION REPORTED THE PATIENT WENT INTO SEVERE WITHDRAWAL AFTER A PUMP REPLACEMENT ON (B)(6) 2014 AND SEIZED ON THE WAY TO THE ER ON (B)(6) 2014. IT WAS REPORTED THE PUMP WAS REMOVED AND THOROUGHLY CHECKED ON (B)(6) 2014 ALONG WITH THE CATHETER WITH A DYE STUDY. IT WAS NOTED THEY DEVELOPED SEVERE SHORT TERM MEMORY PROBLEMS, INCREASED SPASTICITY, DIZZINESS, INABILITY TO STAND OR BALANCE, AND CONFUSION ON (B)(6) 2014 WHICH WAS THE SECOND DAY OF WITHDRAWAL. IT WAS NOTED THE SHORT TERM MEMORY LOSS PROBLEMS WERE STILL THERE AND THE PATIENT WAS HALLUCINATING AND ¿REPEATING THE SAME QUESTIONS EVERY FEW MINUTES ALL DAY.¿ IT WAS STATED THAT IT HAD BEEN 17 DAYS WITH NO RELIEF. IT WAS NOTED THE PATIENT WAS COGNITIVELY FINE EXCEPT FOR SOME LONG TERM MEMORY ISSUES 7 YEARS AFTER THEIR TRAUMATIC BRAIN INJURY AND 6 YEARS SINCE THE INITIAL PUMP IMPLANT. ADDITIONAL INFORMATION REPORTED THE SHUNT WAS CHECKED AND IT WAS FINE, AND THE DYE STUDY CHECKED OK. IT WAS NOTED THE PATIENT WAS HOSPITALIZED FOR SEVERAL DAYS.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 300074 | SYNCHROMED II | PUMP, INFUSION, IMPLANTED, PROGRAMMABLE | LKK | MEDTRONIC PUERTO RICO OPERATIONS CO. | 8637-40 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 00040 YR | Hospitalization| R |