FDA Adverse Event
Injury
Summary report: N
SYNCHROMED II
MDR report key: 1823434
·
Received August 25, 2010
Report
- Report Number
- 3004209178-2010-06454
- Event Type
- Injury
- Date Received
- August 25, 2010
- Report Date
- July 28, 2010
- Manufacturer
- MDT PUERTO RICO OPERATIONS CO., JUNCOS
- Product Code
- LKK
- PMA / PMN Number
- P860004
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- IA, US
- Reporter Occupation
- PHYSICIAN
Narratives
Additional Manufacturer Narrative · 1
(B)(4).
Description of Event or Problem · 1
THE PT MISSED THEIR REFILL DATE AND EXPERIENCED WITHDRAWAL. THE VOLUME IN THE PUMP WAS BELOW RECOMMENDED VOLUME TO MAINTAIN ADEQUATE INFUSION. THE REFILL WAS COMPLETED AND THE DOSE DECREASED. THE DRUG BEING ADMINISTERED VIA THE PUMP WAS LIORESAL. ADDITIONAL INFO HAS BEEN REQUESTED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | SYNCHROMED II | LKK | MDT PUERTO RICO OPERATIONS CO., JUNCOS | 8637-40 | NA |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | EXPLANTED:| EXPLANTED:| IMPLANTED:| CATHETER: MODEL 8709, LOT # J12113R08| CATHETER: MODEL 8578, LOT # N252344001| IMPLANTED: |