SYNCHROMED II
Report
- Report Number
- 3004209178-2011-07792
- Event Type
- Injury
- Date Received
- September 13, 2011
- Date of Event
- August 1, 2011
- Report Date
- January 26, 2012
- 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).
IT WAS REPORTED THAT A PATIENT HAD EXPERIENCED WOUND DEHISCENCE. IT WAS LATER REPORTED THAT THE PATIENT ACQUIRED AN INFECTION FROM THE WOUND DEHISCENCE. THE PATIENT'S PUMP SYSTEM WAS EXPLANTED. IT WAS LATER STATED THAT A "BED-SORE-LIKE SKIN CONDITION" HAD BEEN NOTED AT THE FORMER POCKET SITE IN THE ABDOMEN; THE PATIENT WAS TREATED.
ADDITIONAL INFORMATION: IT WAS NOTED THAT THE PATIENT HAD RECOVERED PER AN ASSESSMENT ON (B)(6) 2011, IN REGARDS TO WOUND MACERATION.
THE DATE OF ONSET OF WOUND DEHISCENCE AND INFECTION WAS (B)(6) 2011. THE SEVERITY WAS STATED AS "MILD". THE PATIENT WAS HOSPITALIZED ON (B)(6) 2011 FOR PUS OOZING FROM A SURGICAL WOUND ON HIS BACK; HE WAS TREATED WITH ANTIBIOTIC IV AND THE WOUND WAS CLEANSED. UNASYN S, 3G/DAY, WAS ALSO ADMINISTERED INTRAVENOUSLY FROM (B)(6) 2011. NO IMPROVEMENT WAS OBSERVED. IT WAS STATED THAT THERE WAS "WITHDRAWAL ON (B)(6)". IT WAS NOT CLEAR WHETHER THIS WAS IN REFERENCE TO WITHDRAWAL SYMPTOMS OR EXPLANT OF THE DEVICE. NO PROBLEMS WERE OBSERVED DURING THE POST-OPERATIVE PERIOD. THE WOUND HEALED AS OF (B)(6) 2011 AND THE PATIENT WAS RE-IMPLANTED ON (B)(6) 2011.
IT WAS REPORTED, THE FAMILY DISCOVERED A DEHISCENCE IN THE PUMP POCKET LOCATED ON THE PATIENT'S BACK. THEY "TOOK A WAIT-AND-SEE APPROACH" SUBSEQUENTLY. WITH REGARD TO THE WOUND DEHISCENCE IN THE BACK, AN INFECTION TOOK HOLD WITHIN THE PUMP POCKET FROM WHICH PUS SEEMED TO DISCHARGE AND RESULTING IN THE DEHISCENCE. ALTHOUGH, THE SITE HAD NOW HARDENED ONCE AGAIN, WITHDRAWAL OR SIMILAR SUCH SYMPTOMS HAD NOT BEEN OBSERVED. THE CAUSE OF THE WOUND DEHISCENCE WAS UNKNOWN. HCP NOTED THE INFECTION HAD INITIATED FROM THE DEHISCENCE IN THE PUMP POCKET ON THE PATIENT'S BACK AND THE CONDITION HAD NOT BEEN AMELIORATED BY TREATMENT, HENCE, FOR SAFETY REASONS, THE REMOVAL OF THE PUMP SYSTEM WAS DECIDED. THE DATE OF ONSET OF INFECTION WAS AFTER (B)(6) 2011. THE PATIENT WAS HOSPITALIZED. THE PATIENT, POST-PUMP REMOVAL, HAD DEVELOPED SYMPTOMS IN THE ABDOMINAL POCKET AREA ANALOGOUS TO BED SORES; THESE WERE BEING TREATED. DATE OF ONSET OF DECUBITUS WAS AFTER (B)(6) 2011. OUTCOME WAS NOTED AS NOT RECOVERED. THE INFECTION WAS NOTED AS BEING UNRELATED TO DRUG, HOWEVER, IT WAS UNKNOWN IF THE INFECTION WAS RELATED TO THE PATIENT'S DEVICE SYSTEM OR PROCEDURE. AS OF (B)(6), THE DAILY DOSE WAS SUBSEQUENTLY REDUCED, TAKING INTO CONSIDERATION THE SYSTEM REMOVAL. THUS, NO WITHDRAWAL SYMPTOMS WERE ANTICIPATED.
ADDITIONAL INFORMATION REPORTED THAT THE PATIENT WAS PLACED ON UNASYN 3 GRAMS IV FOR ADVERSE EVENT. IT WAS FURTHER STATED THAT ON (B)(6) 2011 PATIENT HAD AN INFECTION/WOUND DEHISCENCE. THE SEVERITY WAS REPORTED AS MILD, WITH A SERIOUSNESS SCORE OF ¿3-SERIOUS.¿ THERE WERE DOSE CHANGES AND DRUG THERAPY INTERVENTIONS. CAUSALITY WAS NOTED AS UNKNOWN. PATIENT HAD "WITHDRAWAL ON (B)(6) 2011." THE PATIENT WAS ON THIS ANTIBIOTIC FROM (B)(6) 2011 TO (B)(6) 2011. IT WAS REPORTED THAT ON (B)(6) 2011 THE CATHETER WAS REPLACED. IT WAS NOTED THAT THE PUMP WAS REPLACED ON (B)(6) 2011. IT WAS NOTED THAT THE PATIENT RECOVERED ON (B)(6) 2011.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | SYNCHROMED II | PUMP, INFUSION, IMPLANTED, PROGRAMMABLE | LKK | MDT PUERTO RICO OPERATIONS CO | 8637-20 | NA |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 15 YR | Hospitalization| R | EXPLANTED:| IMPLANTED:| CATHETER: MODEL CATHETER, LOT# UNK |