FDA Adverse Event
Injury
Summary report: N
SYNCHROMED II
MDR report key: 2850861
·
Received November 29, 2012
Report
- Report Number
- 3004209178-2012-10920
- Event Type
- Injury
- Date Received
- November 29, 2012
- Report Date
- November 1, 2012
- 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
- IN, US
- Reporter Occupation
- PHYSICIAN
Narratives
Additional Manufacturer Narrative · 1
(B)(4).
Additional Manufacturer Narrative · 1
PRODUCT ID 8709, SERIAL # (B)(4), IMPLANTED: (B)(6) 2011, EXPLANTED: (B)(6) 2012, PRODUCT TYPE CATHETER. (B)(4).
Description of Event or Problem · 1
IT WAS REPORTED THE PATIENT EXPERIENCED A RETURN OF SPASTICITY. HCP PERFORMED A DYE STUDY AND DETERMINED THERE WAS A TEAR SOMEWHERE ALONG THE CATHETER AND DECIDED TO REPLACE IT COMPLETELY. A REVISION WAS DONE ON (B)(6) 2012 AND THE CATHETER WAS REPLACED. PATIENT STATUS WAS NOTED AS "ALIVE - NO INJURY/NO ADVERSE EVENT." THE PUMP WAS DELIVERING BACLOFEN.
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 | Required Intervention |