FDA Adverse Event
Injury
Summary report: N
SYNCHROMED EL
MDR report key: 3232865
·
Received July 18, 2013
Report
- Report Number
- 6000030-2013-00186
- Event Type
- Injury
- Date Received
- July 18, 2013
- Report Date
- June 26, 2013
- Manufacturer
- RICE CREEK MFG
- Product Code
- LKK
- PMA / PMN Number
- P860004
- Adverse Event
- Yes
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- TX, US
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
CONCOMITANT PRODUCTS: PRODUCT ID 8709, SERIAL # (B)(4), IMPLANTED: (B)(6) 2003, PRODUCT TYPE CATHETER. (B)(4).
Additional Manufacturer Narrative · 1
(B)(4).
Description of Event or Problem · 1
IT WAS REPORTED THAT THE PUMP WAS REPLACED AFTER THE ¿GEARS WENT OUT.¿ IT WAS STATED THAT THE PATIENT HAD FELT SOME VIBRATION IN HIS PRIVATE AREA, WHICH MADE HIM ADDRESS HIS HEALTHCARE PROVIDER. IT WAS SPECIFIED THAT THE BATTERIES WEREN¿T DYING WHEN THE GEARS WENT OUT. THE DRUG BEING DELIVERED BY THE PUMP WAS UNKNOWN FOR THE TIME OF THE EVENT.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 334198 | SYNCHROMED EL | PUMP, INFUSION, IMPLANTED, PROGRAMMABLE | LKK | RICE CREEK MFG | 8627L18 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Required Intervention |