SYNCHROMED II
Report
- Report Number
- 3007566237-2014-01962
- Event Type
- Injury
- Date Received
- July 15, 2014
- Date of Event
- May 24, 2014
- Report Date
- January 20, 2017
- Manufacturer
- MEDTRONIC NEUROMODULATION
- Product Code
- LKK
- PMA / PMN Number
- P860004
- Removal / Correction Number
- Z-1579-2013
- Adverse Event
- Yes
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- TX, US
- Reporter Occupation
- PHYSICIAN
Narratives
CONCOMITANT PRODUCT: PRODUCT ID 8709, SERIAL# (B)(4), IMPLANTED: (B)(6) 2003, PRODUCT TYPE CATHETER. (B)(4)
(B)(4): ANALYSIS RESULTS WERE NOT AVAILABLE AT THE TIME OF THIS REPORT. A FOLLOW-UP REPORT WILL BE SENT WHEN ANALYSIS IS COMPLETED.
THE MAIN DEVICE, OTHER COMPONENTS INCLUDE: PRODUCT ID: 870, SERIAL# (B)(4)IMPLANTED: (B)(6) 2003, PRODUCT TYPE: CATHETER. PRODUCT ID: NEU_UNKNOWN_CATH, PRODUCT TYPE: CATHETER. (B)(4).
PRODUCT ANALYSIS #(B)(4): TECH NOTE: DURING MAX RATE DECONTAMINATION AND 1 REV 24000 UL/DAY DISPENSE TESTING THE PUMP DID NOT APPEAR TO BE DISPENSING FLUID WITH CONFIRMATION THE RESERVOIR HAD FLUID IN IT. DURING DESTRUCTIVE ANALYSIS AMONG OTHER ANOMALIES INCLUDING A BREACH IT WAS FOUND THAT THE OUTLET PORTION OF THE PUMP TUBE HAD MIGRATED TO THE INLET SIDE CREATING A SEVER KINK THAT APPEARS TO OCCLUDE THE TUBE. A VIDEO WAS TAKEN AND IT WAS CONFIRMED THAT THE PUMP HEAD WAS ROTATING PROPERLY BUT FLUID DID NOT APPEAR TO BE ADVANCING PAST THE KINK. BENCH TESTING CONFIRMED THAT AFTER THE PUMP HEAD WAS REMOVED AND THE KING WAS RELIEVED THAT FLUID ONCE AGAIN FLOWED FREELY THROUGH THE TUBE AND OUT THE OUTLET. CONCOMITANT PRODUCTS: PRODUCT ID: 8709, SERIAL# (B)(4), IMPLANTED: (B)(6) 2003, PRODUCT TYPE: CATHETER. PRODUCT ID: NEU_UNKNOWN_CATH, PRODUCT TYPE: CATHETER.
ANALYSIS OF THE PUMP FOUND THERE WAS A HOLE IN THE PUMPHEAD PUMP TUBE DUE TO MECHANICAL WEAR AS WELL AS PUMP TUBE BINDING IN THE PUMP HEAD AND A DEFORMED PUMP TUBE. THERE WAS ALSO A FEEDTHRU ANOMALY SEEN WITH THE MOTOR, SHORTING ACROSS THE INSULATOR WAS SEEN. THE PUMP DID NOT APPEAR TO BE DISPENSING FLUID DURING ANALYSIS WITH CONFIRMATION THE RESERVOIR HAD FLUID IN IT. A BREACH WAS FOUND AS WELL AS THAT THE OUTLET PORTION OF THE PUMP TUBE HAD MIGRATED TO THE INLET SIDE CREATING A SEVERE KINK THAT APPEARED TO OCCLUDE THE TUBE. THE PUMP HEAD WAS CONFIRMED TO BE ROTATING PROPERLY BUT FLUID DIDN¿T APPEAR TO BE ADVANCING PAST THE KINK. AFTER THE PUMPHEAD WAS REMOVED AND THE KINK WAS RELIEVED, FLUID ONCE AGAIN FLOWED FREELY THROUGH THE TUBE AND OUT THE OUTLET.
IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.
(B)(4).
IT WAS REPORTED MULTIPLE MOTOR STALLS AND MOTOR STALL RECOVERIES WERE RECORDED IN THE EVENT LOGS. THE PUMP WAS USED TO DELIVER BACLOFEN (UNKNOWN), FENTANYL AND BUPIVACAINE. IT WAS FURTHER REPORTED THE PATIENT HAD BEEN SCHEDULED FOR AN APPOINTMENT AND MENTIONED SHE THOUGHT SHE NEEDED HER PUMP CHECKED AS W ELL. THE PATIENT THOUGHT SHE IT MIGHT HAVE ALARMED, BUT WAS NOT SURE. THE HEALTHCARE PROFESSIONAL (HCP) WAS IN THE PROCESS OF SCHEDULING A PUMP REPLACEMENT, BUT A DATE HAD NOT BEEN CONFIRMED. THE PATIENT HAD BEEN EXPERIENCING SOME WITHDRAWAL SYMPTOMS, AND WAS BEING MONITORED BY THEIR HCP WHO WAS PRESCRIBING AS NEEDED FOR THE PATIENT'S SYMPTOMS.
INFORMATION CONTAINED WITHIN THE LFC ALSO INDICATED THAT THE PUMP ULTIMATELY DID NOT RECOVER FROM THE MOTOR STALLS AND WENT INTO SAFE STATE MODE OR MOTOR STATE AND EXPERIENCED EARLY FAILURE.
INFORMATION WAS RECEIVED FROM A HEALTHCARE PROVIDER (HCP) VIA A MANUFACTURER¿S REPRESENTATIVE REGARDING A PATIENT WHO WAS RECEIVING 4 ,000 UG/ML OF BACLOFEN AT 1,150.9 UG/ML, 600 UG/ML OF FENTANYL AT 172.63 UG/DAY, AND 20.0 MG/ML OF BUPIVACAINE AT 5.754 MG/DAY VIA AN IMPLANTABLE PUMP BY SIMPLE CONTINUOUS INFUSION FOR SPINAL PAIN. ON 2017-JAN-12, PUMP LOGS WERE PROVIDED BY THE REP VIA THE PATIENT¿S HCP. THE PREVIOUSLY REPORTED MOTOR STALLS AND RECOVERIES OCCURRED AT THE FOLLOWING DATES AND TIMES. MOTOR STALL RECOVERY-(B)(6) 2014, 12:05; MOTOR STALL - (B)(6) 2014, 2:43; MOTOR STALL RECOVERY - (B)(6) 2014, 3:05; MOTOR STALL - (B)(6) 2014, 20:54; MOTOR STALL RECOVERY - (B)(6) 2014, 21:15; MOTOR STALL - (B)(6) 2014, 04:37; MOTOR STALL RECOVERY - (B)(6) 2014, 5:06; MOTOR STALL - (B)(6) 2014, 17:14; MOTOR STALL RECOVERY - (B)(6) 2014, 17:37; MOTOR STALL - (B)(6) 2014, 21:29; MOTOR STALL RECOVERY (B)(6) 2014, 21:38; MOTOR STALL - (B)(6) 2014, 22:34; MOTOR STALL RECOVERY - (B)(6) 2014, 22:47; MOTOR STALL - (B)(6) 2014, 2:09; MOTOR STALL RECOVERY - (B)(6) 2014, 4:04; MOTOR STALL - (B)(6) 2014, 15:06; MOTOR STALL RECOVERY - (B)(6) 2014, 15:55; MOTOR STALL - (B)(6) 2014, 17:57; MOTOR STALL RECOVERY - (B)(6) 2014, 18:06; MOTOR STALL - (B)(6) 2014, 13:50; MOTOR STALL RECOVERY - (B)(6) 2014, 14:09; MOTOR STALL - (B)(6) 2014, 6:25; MOTOR STALL RECOVERY - (B)(6) 2014, 6:44.
ADDITIONAL INFORMATION RECEIVED REPORTED THE BACLOFEN WAS COMPOUNDED. IT WAS FURTHER REPORTED THE PATIENT RECOVERED WITHOUT SEQUELA.
ADDITIONAL INFORMATION RECEIVED REPORTED THE PUMP USED TO WORK BETTER THAN IT DID NOW. THE MANUFACTURER REPRESENTATIVE PULLED THE LOGS AND "ALL THROUGHOUT THE DAY" THE PUMP HAD "MOTOR STALL OCCURRED" MESSAGES WITH RECOVERIES WITHIN 15-60 MINUTES. THE STALLS WERE NOTED TO HAVE RECOVERED WITHIN 2 HOURS. THE PATIENT HAD NOT HAD ANY MRIS. A ROTOR/ROLLER STUDY WAS PERFORMED. THE PUMP HAD AN ERI (ELECTIVE REPLACEMENT INDICATOR) OF 8 MONTHS, BUT THE HEALTHCARE PROFESSIONAL (HCP) WANTED TO REPLACE ANYWAY, ESPECIALLY AFTER THE FINDINGS. THE PUMP WAS EXPLANTED. THE PUMP WAS USED TO DELIVER LIORESAL (BACLOFEN), FENTANYL AND BUPIVACAINE.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 414411 | SYNCHROMED II | PUMP, INFUSION, IMPLANTED, PROGRAMMABLE | LKK | MEDTRONIC NEUROMODULATION | 8637-20 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 00044 YR | Required Intervention |