SYNCHROMED II
Report
- Report Number
- 3004209178-2013-02721
- Event Type
- Injury
- Date Received
- February 15, 2013
- Date of Event
- September 14, 2012
- Report Date
- June 27, 2016
- 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
- IL, US
- Reporter Occupation
- PHYSICIAN
Narratives
(B)(4).
PRODUCT ID: 8709SC, SERIAL# (B)(4), IMPLANTED: (B)(6) 2011, EXPLANTED: (B)(6) 2012-, PRODUCT TYPE: CATHETER. PRODUCT ID: 8590-1, LOT# N242813, IMPLANTED: (B)(6) 2011, EXPLANTED: (B)(6) 2012-, PRODUCT TYPE: ACCESSORY. (B)(4). ANALYSIS OF THE CATHETER FOUND THE CATHETER BODY HAD SIGNIFICANT TWISTING THAT MAY HAVE AFFECTED INFUSION. THE CATHETER WAS RETURNED IN A SINGLE SEGMENT; HOWEVER, THE LABORATORY TECHNICIAN CUT THE CATHETER IN SEGMENTS TO HELP WITH THE PATENCY TESTING. SEGMENTS 2 AND 3 SHOWED MARKINGS THAT WERE SPIRAL IN NATURE, INDICATING SIGNIFICANT TWISTING OCCURRED AT THESE POINTS, THAT MOST LIKELY LED TO THE CATHETER TEAR AND OCCLUSION THAT WAS NOTICED DURING PATENCY TESTING. THE TECHNICIAN WAS UNABLE TO BREAK THE OCCLUSION ON SEGMENTS 2 AND 3. THERE WAS ALSO A NON-SIGNIFICANT INDENT OBSERVED IN THE SEALING SURFACE OF THE SUTURELESS CONNECTOR OF SEGMENT 1.
(B)(4).
(B)(4).
(B)(4).
(B)(4).
(B)(4).
ADDITIONAL INFORMATION REPORTED THAT THE GRADUAL LOSS OF EFFECT FROM PATIENT¿S PUMP SYSTEM TREATMENT WAS DUE TO THE PATIENT¿S SIGNIFICANT WEIGHT LOSS. THE PUMP POCKET LOOSENED AND ALLOWED THE PUMP TO TWIST HUNDREDS OF TIMES CAUSING THE CATHETER TO TWIST AND FAIL TO DELIVER THE MEDICATION.
THE CATHETER WAS RETURNED TO THE MANUFACTURER FROM AN UNKNOWN SOURCE WITH NO RETURN PAPERWORK. THE CATHETER UNDERWENT ROUTINE ANALYSIS.
IT WAS LATER REPORTED A CATHETER DISCONNECTION OCCURRED.
ADDITIONAL INFORMATION WAS RECEIVED AND IT WAS REPORTED THAT SURGICAL OBSERVATION SHOWED THAT THE CATHETER HAD TWISTED MULTIPLE TIMES AND BROKE. THE PUMP WAS DELIVERING INFUMORPH.
IT WAS LATER REPORTED THAT A SURGICAL REVISION WAS PERFORMED ON THE CATHETER AND THE PUMP AS THE PATIENT HAD A GRADUAL LOSS OF EFFECT FROM HER INTRATHECAL MORPHINE TREATMENT. THE CATHETER WAS REPLACED AND THE DEVICE WAS SURGICAL REPOSITIONED ON (B)(6), 2012. REPORTEDLY, THIS ISSUE WAS RELATED TO THE ENTIRE CATHETER BUT WAS NOT RELATED TO THE IMPLANT PROCEDURE. THIS ISSUE WAS RESOLVED WITHOUT SEQUELAE ON (B)(6) 2012.
IT WAS LATER REPORTED THAT THE PUMP WAS INVERTED. THE OUTCOME WAS REPORTED AS RESOLVED WITH SEQUELA ON 2012-(B)(6). THE SEQUELA INCLUDED CATHETER FAILURE TO DELIVER MEDICATION AND THE PATIENT EXPERIENCED LOSS OF TREATMENT EFFECT. IT WAS LATER CONFIRMED THAT THE PUMP HAD ROTATED HUNDREDS OF TIMES CAUSING THE CATHETER TO TWIST.
THE FOLLOWING INFORMATION WAS PREVIOUSLY REPORTED UNDER MANUFACTURER'S REPORT #3004209178-2016-07304 BUT GOING FORWARD WILL BE INCLUDED IN THIS MANUFACTURER'S REPORT #3004209178-2013-02721: INFORMATION WAS RECEIVED FROM A HEALTHCARE PROVIDER REGARDING A PATIENT IN A CLINICAL STUDY WHO WAS RECEIVING MORPHINE WITH CONCENTRATION 25.0 MG/ML AT A DOSE RATE OF 4.902 MG/DAY VIA AN IMPLANTABLE PUMP AS OF (B)(6) 2011 FOR NON-MALIGNANT PAIN AND FAILED BACK SURGERY SYNDROME. IT WAS REPORTED THAT THE PATIENT EXPERIENCED A GRADUAL LOSS OF EFFECT OF TREATMENT. WHEN PALPATED ON (B)(6) 2012, THE PUMPED MOVED FREELY IN THE POCKET. THIS WAS DUE TO THE LARGE AMOUNT OF WEIGHT THE PATIENT HAD LOST. THE CLINICAL DIAGNOSIS WAS PUMP INVERSION. THE CATHETER WAS TWISTED. THE PROGRAMMING DATE FROM THE MOST RECENT REFILL PRIOR TO THE EVENT OCCURRED ON (B)(6) 2012. THE PATIENT WAS RECEIVING INFUMORPH VIA THEIR PUMP AT THE TIME OF THE EVENT. THE EVENT HAD RESULTED IN AN UNSCHEDULED CLINIC / OFFICE VISIT. INTERVENTION INCLUDED THE PUMP HAVING BEEN REPOSITIONED ON (B)(6) 2012. THE EVENT RESOLVED WITHOUT SEQUELAE AS OF (B)(6) 2012. REGARDING ETIOLOGY, THE EVENT WAS NOT RELATED TO THE DEVICE OR THERAPY BUT WAS RELATED TO THE IMPLANT PROCEDURE. ADDITIONAL INFORMATION RECEIVED FROM THE CLINICAL SITE INDICATED THE ENTIRE CATHETER WAS ALSO REMOVED ON (B)(6) 2012 DURING THE PUMP RE-POSITIONING. THE LOCATION OF THE EXPLANTED CATHETER WAS UNKNOWN.
ADDITIONAL INFORMATION RECEIVED REPORTED THE SEQUELA THAT INCLUDED THE CATHETER FAILURE TO DELIVER MEDICATION AND LOSS OF TREATMENT EFFECT ALSO INCLUDED A CATHETER BREAK.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 66455 | SYNCHROMED II | PUMP, INFUSION, IMPLANTED, PROGRAMMABLE | LKK | MDT PUERTO RICO OPERATIONS CO | 8637-40 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 40 YR | Required Intervention |