FDA Adverse Event
Injury
Summary report: N
SYNCHROMED
MDR report key: 3170748
·
Received June 14, 2013
Report
- Report Number
- 3007566237-2013-01987
- Event Type
- Injury
- Date Received
- June 14, 2013
- Report Date
- May 20, 2013
- Manufacturer
- MEDTRONIC
- Product Code
- LKK
- PMA / PMN Number
- P860004
- Adverse Event
- Yes
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- JA
- Reporter Occupation
- PHYSICIAN
Narratives
Additional Manufacturer Narrative · 1
CONCOMITANT MEDICAL PRODUCTS: PRODUCT ID 8711, SERIAL# UNKNOWN, IMPLANTED: (B)(6) 2011. PRODUCT TYPE: CATHETER. (B)(4). (B)(6).
Additional Manufacturer Narrative · 1
(B)(4).
Description of Event or Problem · 1
IT WAS REPORTED THAT WHEN THE CATHETER WAS INSERTED INTRATHECALLY, THERE WAS FRICTION NOTED DURING INSERTION. THE CATHETER COULDN¿T BE EXPLANTED AND THE TIP WAS CLEAVED; IT REMAINED INTRATHECALLY. A NEW CATHETER WAS INSERTED AND POSITIONED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 271327 | SYNCHROMED | PUMP, INFUSION, IMPLANTED, PROGRAMMABLE | LKK | MEDTRONIC | NEU_UNKNOWN_PUMP |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 00016 YR | Other |