FDA Adverse Event
Injury
Summary report: N
SYNCHROMED II
MDR report key: 1972420
·
Received January 24, 2011
Report
- Report Number
- 3004209178-2011-00552
- Event Type
- Injury
- Date Received
- January 24, 2011
- Date of Event
- November 1, 2010
- Report Date
- January 19, 2011
- Manufacturer
- MDT PUERTO RICO OPERATIONS CO., JUNCOS
- Product Code
- LKK
- PMA / PMN Number
- P860004
- Adverse Event
- Yes
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- SP
- Reporter Occupation
- PHYSICIAN
Narratives
Additional Manufacturer Narrative · 1
(B)(4).
Description of Event or Problem · 1
DURING A REFILL SESSION, THE EXPECTED RESIDUAL VOLUME DID NOT MATCH THE ACTUAL VOLUME REMOVED (THE PUMP WAS ALMOST FULL). THE PATIENT WAS SPASTIC. TESTS WERE DONE; THE DETAILS WERE NOT PROVIDED. THE PUMP WAS REPLACED. THE OUTCOME WAS REPORTED AS "RESOLVED". THE PUMP WAS USED TO DELIVER LIORESAL.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | SYNCHROMED II | LKK | MDT PUERTO RICO OPERATIONS CO., JUNCOS | 8637-20 | NA |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Required Intervention |