FDA Adverse Event
Injury
Summary report: N
SYNCHROMED II
MDR report key: 2924455
·
Received January 22, 2013
Report
- Report Number
- 3004209178-2013-00800
- Event Type
- Injury
- Date Received
- January 22, 2013
- Report Date
- December 26, 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
CONCOMITANT MEDICAL PRODUCTS: PRODUCT ID 8709SC, SERIAL# (B)(4), IMPLANTED: (B)(6) 2012. PRODUCT TYPE: CATHETER. (B)(4).
Additional Manufacturer Narrative · 1
(B)(4).
Description of Event or Problem · 1
THE PATIENT'S SKIN OVER THE PUMP WAS THINNING. A REVISION WAS PLANNED. ADDITIONAL INFORMATION HAS BEEN REQUESTED; A FOLLOW-UP REPORT WILL BE SENT IF INFORMATION BECOMES AVAILABLE.
Description of Event or Problem · 1
ADDITIONAL INFORMATION: IT WAS REPORTED THAT THE PUMP WAS REPLACED (B)(6) 2012 BECAUSE IT WAS "STICKING OUT." THE PUMP WAS PLACED DEEPER. THERE WAS NO ERODING OF THE SKIN. THE PATIENT WAS DOING "PERFECTLY FINE," THERE WERE NO ISSUES.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 30243 | SYNCHROMED II | PUMP, INFUSION, IMPLANTED, PROGRAMMABLE | LKK | MDT PUERTO RICO OPERATIONS CO | 8637-20 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Required Intervention |