FDA Adverse Event
Injury
Summary report: N
SYNCHROMED
MDR report key: 2032521
·
Received March 24, 2011
Report
- Report Number
- 3007566237-2011-02248
- Event Type
- Injury
- Date Received
- March 24, 2011
- Date of Event
- March 17, 2011
- Report Date
- March 21, 2011
- Manufacturer
- MEDTRONIC NEUROMODULATION
- Product Code
- LKK
- PMA / PMN Number
- P860004
- Adverse Event
- Yes
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- GR
- Reporter Occupation
- PHYSICIAN
Narratives
Additional Manufacturer Narrative · 1
(B)(4).
Description of Event or Problem · 1
DURING A SCHEDULED REFILL, THE DRUG ASPIRATED BACK WAS THE SAME AS THE DRUG THAT WAS FILLED IN THE PUMP 6 MONTHS PRIOR. A CAP (CATHETER ACCESS PORT) TEST WAS PERFORMED, BUT NO FLUID COULD BE ASPIRATED. X-RAY IMAGES SHOWED CATHETER DISPLACEMENT. THE CATHETER WAS REPLACED. THERE WAS REPORTED TO BE NO PT INJURY. THE DEVICE SYSTEM WAS USED TO DELIVER LIORESAL. ADD'L INFO HAS BEEN REQUESTED, A F/U REPORT WILL BE SENT IF ADD'L INFO BECOMES AVAILABLE.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | SYNCHROMED | LKK | MEDTRONIC NEUROMODULATION | PUMP | NA |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Required Intervention | IMPLANTED:| EXPLANTED:| CATHETER: MODEL 8731SC, LOT # B0950028K |