FDA Adverse Event
Injury
Summary report: N
SYNCHROMED II
MDR report key: 3150785
·
Received June 6, 2013
Report
- Report Number
- 3004209178-2013-08755
- Event Type
- Injury
- Date Received
- June 6, 2013
- Report Date
- May 13, 2013
- Manufacturer
- MDT PUERTO RICO OPERATIONS CO
- Product Code
- LKK
- PMA / PMN Number
- P860004
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- AZ, US
- Reporter Occupation
- PHYSICIAN
Narratives
Additional Manufacturer Narrative · 1
(B)(4).
Additional Manufacturer Narrative · 1
CONCOMITANT PRODUCTS: PRODUCT ID 8835, SERIAL# (B)(4), PRODUCT TYPE PROGRAMMER, PATIENT; PRODUCT ID 8781, SERIAL# (B)(4), IMPLANTED: (B)(6) 2013, PRODUCT TYPE CATHETER. (B)(4).
Description of Event or Problem · 1
ADDITIONAL INFORMATION RECEIVED REPORTED THAT THE PATIENT EXPERIENCED MENINGITIS. THE ENTIRE SYSTEM WAS EXPLANTED ON 5/13/2013, AND THE PATIENT WAS TREATED WITH IV ANTIBIOTICS. THE DIAGNOSTIC LAB RESULTS DETERMINED THE PATIENT HAD (B)(6).
Description of Event or Problem · 1
IT WAS REPORTED THAT THERE WAS AN EVENT WHICH RESULTED IN AN IN-PATIENT OR PROLONGED HOSPITALIZATION. NO FURTHER DETAILS WERE REPORTED. THE PUMP WAS USED TO DELIVER DILAUDID, BUPIVICAINE AND CLONIDINE.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 250258 | SYNCHROMED II | PUMP, INFUSION, IMPLANTED, PROGRAMMABLE | LKK | MDT PUERTO RICO OPERATIONS CO | 8637-40 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Hospitalization| R |