FDA Adverse Event
Injury
Summary report: N
SYNCHROMED II
MDR report key: 3200102
·
Received July 1, 2013
Report
- Report Number
- 3004209178-2013-11135
- Event Type
- Injury
- Date Received
- July 1, 2013
- Report Date
- June 7, 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
- NY, US
- Reporter Occupation
- PHYSICIAN
Narratives
Additional Manufacturer Narrative · 1
CONCOMITANT PRODUCTS: PRODUCT ID 8780, SERIAL# (B)(4), IMPLANTED: (B)(6) 2013, PRODUCT TYPE CATHETER. (B)(4).
Additional Manufacturer Narrative · 1
(B)(4).
Description of Event or Problem · 1
A REPRESENTATIVE REPORTED THAT THE PATIENT WAS SCHEDULED FOR A REVISION ON (B)(6) 2013. THE PATIENT HAD A POCKET OF FLUID ACCUMULATING IN HER BACK NEAR THE IMPLANTED CATHETER SITE. THE PATIENT ALSO HAD A LOSS OF THERAPEUTIC EFFECT DEMONSTRATED BY AN INCREASE IN SPASTICITY.
Description of Event or Problem · 1
A HEALTHCARE PROVIDER LATER REPORTED THAT THE CAUSE OF THE EVENT WAS A CATHETER DISLODGEMENT/MIGRATION, AND CONFIRMED THE SYMPTOMS WERE A FLUID COLLECTION AT THE LUMBAR SITE. A SURGICAL REVISION OF THE CATHETER OCCURRED, AND THE PATIENT REQUIRED HOSPITALIZATION. THE PATIENT RECOVERED WITHOUT SEQUELAE.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 299576 | SYNCHROMED II | PUMP, INFUSION, IMPLANTED, PROGRAMMABLE | LKK | MDT PUERTO RICO OPERATIONS CO | 8637-40 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 00068 YR | Hospitalization| R |