FDA Adverse Event
Injury
Summary report: N
SYNCHROMED II
MDR report key: 3000369
·
Received March 12, 2013
Report
- Report Number
- 3004209178-2013-03605
- Event Type
- Injury
- Date Received
- March 12, 2013
- Report Date
- February 12, 2013
- 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
- MN, US
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
CONCOMITANT MEDICAL PRODUCTS: PATIENT PROGRAMMER: MODEL: ID 8835, SERIAL# (B)(4). CATHETER: MODEL: ID 8709SC, SERIAL# (B)(4), IMPLANTED: (B)(6) 2010, EXPLANTED: (B)(6) 2013. CATHETER: MODEL: 8598A, SERIAL# (B)(4), IMPLANTED: (B)(6) 2013, EXPLANTED:UNKNOWN. (B)(4).
Description of Event or Problem · 1
IT WAS REPORTED THAT A DYE STUDY SHOWED A SUSPECTED CATHETER MIGRATION INTO EPIDURAL SPACE. AT THE TIME OF SURGERY WHEN THE SPINAL SEGMENT OF THE CATHETER WAS REMOVED THERE WAS CEREBRAL SPINAL FLUID RETURN AND A NEW CATHETER SPINAL SEGMENT WAS IMPLANTED. THE PATIENT HAD SYMPTOMS INCLUDING PAIN. THE PUMP WAS INFUSING BUPIVACAINE AND INFUMORPH.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 103895 | SYNCHROMED II | PUMP, INFUSION, IMPLANTED, PROGRAMMABLE | LKK | MDT PUERTO RICO OPERATIONS CO | 8637-20 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |