SYNCHROMED EL
Received May 19, 2016
Report 3007566237-2016-02051 · MDR key 5667264
Device
Generic name
Legging, Compression, Non-inflatable
Manufacturer
Rice Creek MfgModel number
8627L18Catalog number
8627L18
Product problems
- Device Or Device Fragments Location Unknown
- Material Integrity Problem
- Device Or Device Fragments Location Unknown
- Material Integrity Problem
Patient
Not reported
- Device Embedded In Tissue or Plaque
- Device Embedded In Tissue or Plaque
Narrative
Additional Manufacturer Narrative
CONCOMITANT MEDICAL PRODUCTS: PRODUCT ID: 8709, SERIAL# (B)(4), IMPLANTED: (B)(6) 2004, EXPLANTED: (B)(6) 2016, PRODUCT TYPE: CATHETER. CORRECTED INFORMATION: ADDITIONAL INFORMATION RECEIVED INDICATED THE CORRECT MANUFACTURING SITE NUMBER FOR THIS EVENT IS (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.
Description of Event or Problem
ADDITIONAL INFORMATION RECEIVED REPORTED THAT THE CATHETER THAT WAS IMPLANTED IN THE PATIENT¿S ORIGINAL PUMP BROKE. A DYE TEST WAS DONE WHICH CONFIRMED THE BROKEN CATHETER AND THE PATIENT HAD PIECE OF THE BROKEN CATHETER AT THE BOTTOM OF THEIR SPINE. PER THE PATIENT THE SURGERY TO REMOVE THE PIECE OF CATHETER WAS TOO RISKY. THE PUMP AND CATHETER HAD TO BE REPLACED. THE PUMP WAS REPLACED DUE TO NORMAL BATTERY DEPLETION. THE PATIENT STATED THEY DIDN¿T KNOW WHAT CAUSED THE CATHETER TO BREAK.
Additional Manufacturer Narrative
OTHER APPLICABLE COMPONENTS ARE: PRODUCT ID: NEU_UNKNOWN_CATH, PRODUCT TYPE: CATHETER.
Description of Event or Problem
INFORMATION WAS RECEIVED FROM CONSUMER VIA A COMPANY REPRESENTATIVE REGARDING A PATIENT RECEIVING PRIALT DOSE AND CONCENTRATION NOT REPORTED VIA AN IMPLANTABLE PUMP. THE INDICATION FOR USE WAS NON-MALIGNANT PAIN. PER THE REPORTER DURING A REPLACEMENT RECENTLY THE CATHETER BROKE AND PART OF IT WAS LODGED IN THE PATIENT'S SPINAL COLUMN. THE PATIENT STATED THAT THEIR PHYSICIAN SAID THAT THE PRIALT BEING RELEASED INTO THEIR SYSTEM WAS STABLE AND SAFE, HOWEVER THE PATIENT HAD TO INCREASE THEIR USE OF ORAL NARCOTICS AND WAS VERY WORRIED THEY WOULD END UP IN THE HOSPITAL VERY SOON. THE PATIENT HAD BEEN UNHAPPY WITH THEIR PREVIOUS PHYSICIAN WHICH RESULTED IN THE PATIENT SWITCHING PHYSICIANS.
Description of Event or Problem
ADDITIONAL INFORMATION WAS RECEIVED FROM A CONSUMER STATING THE PATIENT'S CATHETER BROKE AND THE HEALTHCARE PROVIDED DID NOT DIAGNOSE IT RIGHT AWAY, RESULTING IN PRIALT BEING DELIVERED INTO THE PATIENT'S SOFT TISSUE INSTEAD OF INTO THE CSF.
Additional Manufacturer Narrative
(B)(4).
Description of Event or Problem
ADDITIONAL INFORMATION WAS RECEIVED FROM A CONSUMER. IT WAS NOTED THE CATHETER ALSO LEAKED.
Additional Manufacturer Narrative
IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.