FDA Adverse Event
Malfunction
Summary report: N
SYNCHROMED II
MDR report key: 3173669
·
Received June 17, 2013
Report
- Report Number
- 3004209178-2013-10453
- Event Type
- Malfunction
- Date Received
- June 17, 2013
- Date of Event
- May 24, 2013
- Report Date
- May 24, 2013
- Manufacturer
- MDT PUERTO RICO OPERATIONS CO
- Product Code
- LKK
- PMA / PMN Number
- P860004
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- MN, US
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
PRODUCT ID 8731, SERIAL# (B)(4), IMPLANTED: 2006-(B)(6), PRODUCT TYPE CATHETER PRODUCT ID 8840, PRODUCT TYPE PROGRAMMER, (B)(4).
Description of Event or Problem · 1
IT WAS REPORTED THAT THE PHYSICIAN DID NOT WANT TO WAIT FOR A BACK TABLE PRIME, SO THEY DID NOT ASPIRATE THE CATHETER. THEY CONNECTED THE PUMP THAT WAS FULL OF DRUG. THERE WAS STILL WATER IN THE INTERNAL PUMP TUBING. IT WAS LATER DISCUSSED THAT THE PHYSICIAN INTENDED TO WITHDRAW FROM THE CATHETER ACCESS PORT AND PRIME THE CATHETER VOLUME UNTIL THE STERILE WATER WAS CLEARED FROM THE INTERNAL TUBING. NO PATIENT SYMPTOMS WERE REPORTED. THE MEDICATION USED WITHIN THE SYSTEM WAS BACLOFEN.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 273723 | SYNCHROMED II | PUMP, INFUSION, IMPLANTED, PROGRAMMABLE | LKK | MDT PUERTO RICO OPERATIONS CO | 863720 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 00017 YR |