SYNCHROMED II
Report
- Report Number
- 3004209178-2013-03389
- Event Type
- Injury
- Date Received
- March 6, 2013
- Date of Event
- January 19, 2013
- Report Date
- July 27, 2017
- Manufacturer
- MDT PUERTO RICO OPERATIONS CO
- Product Code
- LKK
- PMA / PMN Number
- P860004
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- JA
- Reporter Occupation
- PHYSICIAN
Narratives
(B)(4)
(B)(4).
(B)(4).
(B)(4).
(B)(4).
(B)(6). IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.
IT WAS LATER REPORTED THAT THE CAUSE OF THE SEPSIS WAS NOT IDENTIFIED, ¿THE CASUAL RELATIONSHIP TO THE DRUG WAS ASSESSED ¿POSSIBLE,¿¿ THE REASON FOR THIS WAS NOTED AS ¿DECREASE IN MUSCLE TONE (ALTHOUGH THIS IS THE GOAL OF THE THERAPY) DUE TO BACLOFEN POSSIBLY WORSENED THE MORBID HYPOTONIA DURING POOR PHYSICAL CONDITION, WHICH WAS PECULIAR TO CHILD. "SERRATIA" WAS ALWAYS OF DETERIORATION IN EXPECTORATION CAPABILITY. ON (B)(6) 2013 THE PATIENT DEVELOPED A FEVER AND WAS HOSPITALIZED. ON (B)(6) 2013 LOW PLATELET COUNT, ¿ETC¿ WAS OBSERVED. ON (B)(6) 2013 ¿GA INTRASPINAL INJECTION.¿ ON (B)(6) 2011 (UNCLEAR IF IT WAS MEANT (B)(6) 2013) ¿GA IMPLEMENTED, NO ABNORMALITIES,¿ TRANSFERRED TO A DIFFERENT HOSPITAL, ¿SAME THERAPY AS BY PREVIOUS PHYSICIAN WAS CONTINUED.¿ ON (B)(6) 2013 CRP<(> <<)>1.0 OBSERVED. IT WAS NOTED REGARDING THE INFECTION THAT STARTED ON (B)(6) 2013 THAT IT WAS UNCLEAR WHETHER THE ITB (INTRATHECAL BACLOFEN) SYSTEM CAUSED THE INFECTION OR IF THE ITB SYSTEM AGGRAVATED THE INFECTION. THE EXAMINATION OF CEREBROSPINAL FLUID PERFORMED AT THIS HOSPITAL INDICATED NORMAL CEREBROSPINAL FLUID CULTURE/NEGATIVE SO THIS WAS NOT A CASE OF MENINGITIS, ETC. THERE IS DOUBT AS TO WHETHER IT IS POSSIBLE FOR AN INFECTION OF THE ITB SYSTEM TO CAUSE SEPSIS WITHOUT CAUSING MENINGITIS. HOWEVER, SEPSIS WAS 2-TIME AND THE ITB SYSTEM MAY HAVE AFFECTED IN SOME WAY.
IT WAS REPORTED THAT ON (B)(6) 2013 THE PATIENT DEVELOPED A FEVER. THREE DAYS LATER THE PATIENT WAS ADMITTED TO THE HOSPITAL FOR "POOR HEALTH". PYOCYANIN AND SERRATIA WERE IDENTIFIED IN TWO CULTURES OF SAMPLED BLOOD. THIS WAS WHY SEPSIS WAS SUSPECTED. THE PATIENT WAS TREATED WITHOUT SATISFACTION. ON (B)(6) 2013, THE PATIENT CHANGED HOSPITALS TO CONTINUE THE TREATMENT. ANTIBIOTICS WERE GIVEN TO THE PATIENT. NO REDDENING, SWELLING, OR HEAT WAS OBSERVED AT THE IMPLANTATION SITE. PNEUMONIA WAS THE ONLY OBVIOUS SYMPTOM IN THE PREVIOUS HOSPITAL. WITH THIS PARTICULAR CASE, SEPSIS HAD NOT BEEN SUSPECTED UNTIL THIS OCCASION AFTER THERAPY INITIATION; THEREFORE, IT WAS DETERMINED THAT THE RELATIONSHIP OF THE PATIENT'S SYMPTOMS TO THE THERAPY COULD NOT BE DENIED. THE PATIENT WAS RECOVERING.
ADDITIONAL INFORMATION: THE PATIENT WAS TREATED WITH IV (INTRAVENOUS) UNASYN, SEFIROM, AND MEROPEN. ON (B)(6) 2013 THE PATIENT¿S ¿CRP¿ WAS 0.12 AND THE ADMINISTRATION OF ANTIBIOTICS WAS ENDED. ON (B)(6) 2013 THE PATIENT¿S ¿CRP¿ WAS 0.1. THE PATIENT WAS ASSESSED AS RECOVERING AS OF 02/19/2013. THE SEVERITY OF THE EVENT WAS NOTED TO BE ¿MODERATE¿. ON (B)(6) 2013, THE PATIENT DEVELOPED A FEVER AND WAS HOSPITALIZED FOR SEPSIS; SERRATIA MARCESCENS WAS DETECTED IN HIS BLOOD. ON (B)(6) 2013 A LOW PLATELET COUNT WAS OBSERVED. THE NEXT DAY A ¿GA INTRASPINAL INJECTION¿ WAS GIVEN. ON (B)(6) 2013, IT WAS NOTED THAT ¿GA=NO ABNORMALITIES¿ AND THE PATIENT WAS TRANSFERRED TO ANOTHER HOSPITAL WITH THE PREVIOUS PHYSICIAN¿S TREATMENT COURSE. THE PATIENT WAS TREATED WITH IV ALLER, HEPARIN, MEROPEN, FOY, AND RANITIDINE. THE PATIENT'S ¿CRP¿ WAS <(><<)>1.0. CULTURE TESTS WERE PERFORMED AT VARIOUS SITES, INCLUDING THE PHARYNX AND BLOOD. IT WAS UNCLEAR WHETHER THE INTRATHECAL BACLOFEN SYSTEM CAUSED THE INFECTION OR IF THE INTRATHECAL BACLOFEN SYSTEM AGGRAVATED THE INFECTION. NO SIGNS OF INFECTION WERE OBSERVED AROUND THE DEVICE. THE EXAMINATION OF THE CEREBROSPINAL FLUID PERFORMED AT THE SECOND HOSPITAL INDICATED NORMAL CEREBROSPINAL FLUID; CULTURE NEGATIVE, SO IT WAS NOT A CASE OF MENINGITIS. THERE WAS DOUBT AS TO WHETHER THE INTRATHECAL BACLOFEN SYSTEM COULD CAUSE SEPSIS WITHOUT CAUSING MENINGITIS. HOWEVER, THIS WAS THE SECOND TIME THE PATIENT HAD SEPSIS, SO THE INTRATHECAL BACLOFEN SYSTEM MAY HAVE BEEN RELATED FOR SOME REASON. REMOVAL OF THE PUMP SYSTEM WILL BE CONSIDERED IF IT RECURS. THE SEVERITY OF THE EVENT WAS NOTED TO BE ¿MODERATE¿. THE PATIENT RECOVERED ON (B)(6) 2013. CORRECTED INFORMATION: THE DEVICE SYSTEM WAS DELIVERING GABALON.
IT WAS REPORTED THAT THE PATIENT WAS ADMITTED TO A HOSPITAL FOR HIS ''ILL HEALTH''. FIVE WEEKS LATER, IT WAS REPORTED THAT THE PATIENT WAS SUSPECTED OF HAVING SEPSIS. THE PATIENT WAS ADMITTED TO ANOTHER HOSPITAL TO BE EXAMINED. IT WAS SPECIFICALLY NOTED THAT A CEREBROSPINAL FLUID TEST WOULD BE CONDUCTED. AT THE TIME OF REPORT, IT WAS UNCLEAR WHETHER THE DEVICE SYSTEM WAS RELATED TO THE EVENT. THE DRUG USED IN THIS SYSTEM WAS LIORESAL.
ADDITIONAL INFORMATION LATER REPORTED THE OUTCOME WAS NOTED AS RECOVERED (B)(6) 2013.
ADDITIONAL INFORMATION WAS RECEIVED. IT WAS REPORTED THAT THE PATIENT HAD A HIGH DOSE OF BACLOFEN (23.5 MCG/KG/DAY). IT WAS REPORTED THAT REMARKABLE MUSCLE RELAXATION WAS OBSERVED IN THE PATIENT WHEN THE PATIENT SUFFERED INFECTION, REQUIRING ARTIFICIAL RESPIRATION MANAGEMENT. NO FURTHER COMPLICATIONS WERE REPORTED AND/OR ANTICIPATED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 95301 | SYNCHROMED II | PUMP, INFUSION, IMPLANTED, PROGRAMMABLE | LKK | MDT PUERTO RICO OPERATIONS CO | 8637-20 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 00005 YR | Hospitalization| O |