FDA Adverse Event
Injury
Summary report: N
SYNCHROMED II
MDR report key: 2891062
·
Received December 31, 2012
Report
- Report Number
- 3004209178-2012-12393
- Event Type
- Injury
- Date Received
- December 31, 2012
- Report Date
- December 3, 2012
- Manufacturer
- MDT PUERTO RICO OPERATIONS CO
- Product Code
- LKK
- PMA / PMN Number
- P860004
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- FL, US
- Reporter Occupation
- PHYSICIAN
Narratives
Additional Manufacturer Narrative · 1
(B)(4).
Additional Manufacturer Narrative · 1
PRODUCT ID, 8780 LOT# SERIAL# (B)(4), IMPLANTED: 2012 (B)(6), EXPLANTED: 2012 (B)(6), PRODUCT TYPE CATHETER. (B)(4).
Additional Manufacturer Narrative · 1
(B)(4).
Description of Event or Problem · 1
THE PATIENT EXPERIENCED AN INFECTION ON AN UNKNOWN DATE. THE PATIENT'S PUMP AND CATHETER WERE EXPLANTED. THERE WERE NO PATIENT SYMPTOMS OR INJURIES REPORTED TO BE RELATED TO THIS EVENT. ADDITIONAL INFORMATION HAS BEEN REQUESTED, BUT IT WAS NOT AVAILABLE AT THE TIME OF THIS EVENT.
Description of Event or Problem · 1
ADDITIONAL INFORMATION WAS RECEIVED. IT WAS REPORTED THAT THE PATIENT WAS "DOING FINE" POST-EXPLANT. IT WAS NOTED THAT THE PATIENT ALSO HAD AN EXPECTED RETURN OF SPASTICITY.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | SYNCHROMED II | PUMP, INFUSION, IMPLANTED, PROGRAMMABLE | LKK | MDT PUERTO RICO OPERATIONS CO | 8637-40 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 00013 YR | Hospitalization| R |