FDA Adverse Event
Injury
Summary report: N
SYNCHROMED II
MDR report key: 3201277
·
Received July 2, 2013
Report
- Report Number
- 3007566237-2013-00574
- Event Type
- Injury
- Date Received
- July 2, 2013
- Date of Event
- September 14, 2011
- Report Date
- September 14, 2011
- Manufacturer
- MEDTRONIC NEUROMODULATION
- Product Code
- LKK
- PMA / PMN Number
- P860004
- Adverse Event
- Yes
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- MN, US
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
CONCOMITANT PRODUCT: PRODUCT ID 8709, SERIAL # (B)(4), IMPLANTED: (B)(6) 2005, EXPLANTED: (B)(6) 2011, PRODUCT TYPE CATHETER. (B)(4).
Description of Event or Problem · 1
IT WAS REPORTED THAT DURING A PUMP REPLACEMENT FOR END OF LIFE, THE SURGEON ATTEMPTED TO POSITION THE CATHETER HIGHER IN THE INTRATHECAL SPACE. IT WAS NOTED THAT WHEN HE PULLED IT OUT IT LOOKED LIKE IT HAD TORN. THE WHOLE CATHETER WAS REPLACED INSTEAD. IT WAS REPORTED THAT THE PATIENT WAS GETTING GOOD THERAPY BEFORE THE REVISION, BUT THE PATENCY OF THE OLD CATHETER WAS UNKNOWN. THE DRUG IN THE PUMP WAS BACLOFEN.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 301559 | SYNCHROMED II | PUMP, INFUSION, IMPLANTED, PROGRAMMABLE | LKK | MEDTRONIC NEUROMODULATION | 863720 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 00051 YR | Required Intervention |