FDA Adverse Event
Injury
Summary report: N
SYNCHROMED II
MDR report key: 3112665
·
Received May 14, 2013
Report
- Report Number
- 3004209178-2013-07672
- Event Type
- Injury
- Date Received
- May 14, 2013
- Report Date
- April 16, 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
- AS
- Reporter Occupation
- PHYSICIAN
Narratives
Additional Manufacturer Narrative · 1
(B)(4).
Additional Manufacturer Narrative · 1
A SMALL PIECE OF CATHETER WAS RETURNED AND ANALYSIS OF THE SAME REVEALED A USER RELATED HOLE IN THE CATHETER BODY.
Additional Manufacturer Narrative · 1
CATHETER MODEL: 8709SC, SERIAL# UNKNOWN, EXPLANTED: 2013-(B)(6). (B)(4).
Description of Event or Problem · 1
IT WAS REPORTED THAT THE PUMP WAS IN A POSITION THAT WAS UNCOMFORTABLE WHEN PATIENT WAS SITTING. PATIENT UNDERWENT A SURGICAL REVISION WHEREIN THE PUMP WAS MOVED ON TUESDAY (B)(6). AT THE TIME OF SURGERY, A HOLE IN THE CATHETER AT THE CONNECTION POINT WAS NOTICED. THE CATHETER WAS REVISED/REPLACED. PATIENT WENT HOME TWO DAYS LATER AND HAD NOT REPORTED ANY ISSUES THEREAFTER, REPORTER THEREFORE NOTED THAT PATIENT MAY BE OK. DRUGS DELIVERED VIA THE DEVICE WERE THE MORPHINE AND CLONIDINE.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 213434 | SYNCHROMED II | PUMP, INFUSION, IMPLANTED, PROGRAMMABLE | LKK | MDT PUERTO RICO OPERATIONS CO | 8637-40 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Required Intervention |