FDA Adverse Event
Injury
Summary report: N
SYNCHROMED II
MDR report key: 1901957
·
Received November 12, 2010
Report
- Report Number
- 3004209178-2010-09413
- Event Type
- Injury
- Date Received
- November 12, 2010
- Date of Event
- February 2, 2010
- Report Date
- October 28, 2010
- Manufacturer
- MDT PUERTO RICO OPERATIONS CO., JUNCOS
- Product Code
- LKK
- PMA / PMN Number
- P860004
- Adverse Event
- Yes
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- AZ, US
- Reporter Occupation
- PHYSICIAN
Narratives
Additional Manufacturer Narrative · 1
(B)(4).
Description of Event or Problem · 1
IT WAS REPORTED THAT THE PATIENT EXPERIENCED INCREASING PAIN DUE TO CATHETER MIGRATION FROM THE INTRATHECAL SPACE. AN X-RAY REVEALED THAT THE CATHETER WAS AT T12-L1. THE CATHETER WAS SURGICALLY REVISED IN (B)(6), AND THE PATIENT RECOVERED WITHOUT SEQUELA. LATER IT WAS REPORTED THAT TH PATIENT AGAIN EXPERIENCED INCREASED PAIN DUE TO CATHETER MIGRATION FROM THE INTRATHECAL SPACE. INFUSION RATE HAD BEEN INCREASED WITH NO RELIEF. THE CATHETER WAS REPOSITIONED IN (B)(6), AND THE PATIENT RECOVERED WITHOUT SEQUELA. THE MEDICATION BEING DELIVERED VIA THE DEVICE SYSTEM WAS NOT REPORTED. ADDITIONAL INFORMATION HAS BEEN REQUESTED, A FOLLOW-UIP DEVICE WILL BE SENT IF ADDITIONAL INFORMATION BECOMES AVAILABLE.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | SYNCHROMED II | LKK | MDT PUERTO RICO OPERATIONS CO., JUNCOS | 8637-40 | NA |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 57 YR | Required Intervention | PROGRAMMER: MODEL #8835, LOT #NOG014452N| IMPLANTED:| EXPLANTED:| CATHETER: MODEL 8709, LOT #N213023015| EXPLANTED:| IMPLANTED:| EXPLANTED:| CATHETER: MODEL 8709, LOT #N213027004| IMPLANTED: |