FDA Adverse Event
Injury
Summary report: N
SYNCHROMED II
MDR report key: 3627154
·
Received February 13, 2014
Report
- Report Number
- 3004209178-2014-02988
- Event Type
- Injury
- Date Received
- February 13, 2014
- Report Date
- January 27, 2014
- Manufacturer
- MDT PUERTO RICO OPERATIONS CO
- 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 MEDICAL PRODUCTS: PRODUCT ID 8731SC, SERIAL# (B)(4), IMPLANTED: 2010-(B)(6), PRODUCT TYPE CATHETER. (B)(4).
Additional Manufacturer Narrative · 1
(B)(4).
Description of Event or Problem · 1
IT WAS REPORTED THE CATHETER WAS DISLODGED. IT WAS STATED THAT THE CATHETER BECAME DISLODGED SOMEHOW IN 2011 AND NEEDED TO BE REPLACED. IT WAS NOTED THE PATIENT HAD THE IMPRESSION THAT IT ¿WASN¿T TIED DOWN SECURED VERY GOOD ORIGINALLY.¿ IT WAS STATED IT ¿DISLODGED, BROKE OR SOMETHING¿ BUT THE PATIENT DID NOT KNOW. THE PUMP WAS USED TO DELIVER BACLOFEN. PATIENT OUTCOME WAS NOT PROVIDED. ADDITIONAL INFORMATION HAS BEEN REQUESTED, BUT WAS NOT AVAILABLE AS OF THE DATE OF THIS REPORT.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 94533 | SYNCHROMED II | PUMP, INFUSION, IMPLANTED, PROGRAMMABLE | LKK | MDT PUERTO RICO OPERATIONS CO | 8637-40 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 00061 YR | Required Intervention |