FDA Adverse Event
Malfunction
Summary report: N
SYNCHROMED II
MDR report key: 2853695
·
Received December 3, 2012
Report
- Report Number
- 3004209178-2012-11038
- Event Type
- Malfunction
- Date Received
- December 3, 2012
- Date of Event
- November 5, 2012
- Report Date
- November 5, 2012
- Manufacturer
- MDT PUERTO RICO OPERATIONS CO
- Product Code
- LKK
- PMA / PMN Number
- P860004
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- KY, US
- Reporter Occupation
- PHYSICIAN
Narratives
Additional Manufacturer Narrative · 1
CATHETER MODEL: 8780, SERIAL # (B)(4), IMPLANTED/EXPLANTED: NOT IMPLANTED AND DISCARDED.
Additional Manufacturer Narrative · 1
(B)(4).
Description of Event or Problem · 1
IT WAS REPORTED DURING AN IMPLANT PROCEDURE THE PHYSICIAN FELT RESISTANCE ADVANCING CATHETER. HE WAS NOT CONFIDENT IF THE CATHETER LOOPED BACK ON ITSELF AS HE COULD NOT SEE THE CATHETER BODY UNDER FLUOROSCOPY AND WAS DISPLEASED WITH IT. WHEN HE PULLED THE CATHETER OUT THERE WAS AN "OBVIOUS BEND IN THE CATHETER AND STYLET"; A CATHETER KINK WAS STATED. PHYSICIAN ABANDONED THIS CATHETER AND USED AN 8709 SC INSTEAD. THE CATHETER WAS DISCARDED. DRUG DELIVERED VIA THE DEVICE WAS BACLOFEN. NO ADVERSE SYMPTOMS WERE EXPERIENCED BY THE PATIENT DURING THE PROCEDURE.
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 | 00055 YR |