FDA Adverse Event
Injury
Summary report: N
SYNCHROMED II
MDR report key: 3266752
·
Received August 6, 2013
Report
- Report Number
- 3004209178-2013-12845
- Event Type
- Injury
- Date Received
- August 6, 2013
- Report Date
- July 15, 2013
- Manufacturer
- MDT PUERTO RICO OPERATIONS CO
- Product Code
- LKK
- PMA / PMN Number
- P860004
- Removal / Correction Number
- Z-1151-2008
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- MN, US
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
CONCOMITANT PRODUCTS: PRODUCT ID 8709, LOT # J11269R18, IMPLANTED: (B)(6) 2002, PRODUCT TYPE CATHETER. (B)(4).
Description of Event or Problem · 1
AN INFLAMMATORY MASS WAS REPORTED. IT WAS ADDED THAT PATIENT WAS ON A "CRAZY-HIGH" CONCENTRATION OF DILAUDID, "LIKE 50 MG/ML" AND A NEW PHYSICIAN HAD JUST UNDERTAKEN HIS CARE. CURRENTLY THE PUP HAD SALINE IN IT. ADDITIONAL INFORMATION HAS BEEN REQUESTED; A FOLLOW-UP REPORT WILL BE SENT WHEN IT BECOMES AVAILABLE.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 368292 | SYNCHROMED II | PUMP, INFUSION, IMPLANTED, PROGRAMMABLE | LKK | MDT PUERTO RICO OPERATIONS CO | 8637-40 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Other |