FDA Adverse Event
Injury
Summary report: N
SYNCHROMED II
MDR report key: 2230743
·
Received August 23, 2011
Report
- Report Number
- 3004209178-2011-06701
- Event Type
- Injury
- Date Received
- August 23, 2011
- Report Date
- July 29, 2011
- Manufacturer
- MDT PUERTO RICO OPERATIONS CO., JUNCOS
- Product Code
- LKK
- PMA / PMN Number
- P860004
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- MN, US
- Reporter Occupation
- NOT APPLICABLE
Narratives
Additional Manufacturer Narrative · 1
(B)(4).
Description of Event or Problem · 1
THE PATIENT EXPERIENCED PSYCHOSIS "AT HIGH LEVELS OF MEDICATION." IT WAS ALSO NOTED THE PATIENT HAS OVERDOSED FROM ORAL MEDICATIONS ON 2 OCCASIONS RECENTLY; ONCE FROM TRAZODONE, AND ONCE FROM COUMADIN. IT WAS LATER REPORTED ON (B)(6) 2011 THAT A PUMP DYE STUDY WAS "FINE". THE DRUG DELIVERED VIA THE PUMP WAS LIORESAL.
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 | Other | EXPLANTED:| CATHETER: MODEL 8709SC, LOT# N159303011| IMPLANTED: |