FDA Adverse Event
Malfunction
Summary report: N
SYNCHROMED II
MDR report key: 3120134
·
Received May 20, 2013
Report
- Report Number
- 3004209178-2013-07890
- Event Type
- Malfunction
- Date Received
- May 20, 2013
- Report Date
- April 22, 2013
- 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
- IN, US
- Reporter Occupation
- PATIENT
Narratives
Additional Manufacturer Narrative · 1
CONCOMITANT PRODUCTS: PRODUCT ID 8709SC, SERIAL# (B)(4), IMPLANTED: (B)(6) 2011, PRODUCT TYPE CATHETER. (B)(4).
Description of Event or Problem · 1
IT WAS REPORTED THAT THE PATIENT STARTED FEELING LIKE SHE WAS GOING THROUGH WITHDRAWALS - BURNING UP, DRIPPING IN SWEAT, CHILLS, FREEZING, CLAMMY, DIDN'T WANT TO EAT, FELT LIKE SHE WAS GOING TO GET SICK - THIS STARTED A COUPLE OF DAYS AGO WHEN SHE STARTED TANNING. THE PHYSICIAN HAD ALSO JUST INCREASED MEDICATION CONCENTRATION. THE PATIENT HAS GONE THROUGH WITHDRAWALS BEFORE, WHEN SHE WAS ON ORAL MORPHINE AND REPORTS KNOWING WHAT IT FEELS LIKE.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 222378 | SYNCHROMED II | PUMP, INFUSION, IMPLANTED, PROGRAMMABLE | LKK | MDT PUERTO RICO OPERATIONS CO | 8637-20 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |