FDA Adverse Event
Injury
Summary report: N
UNKNOWN PUMP
MDR report key: 1081327
·
Received July 24, 2008
Report
- Report Number
- 2182207-2008-04361
- Event Type
- Injury
- Date Received
- July 24, 2008
- Date of Event
- June 1, 2008
- Report Date
- June 25, 2008
- 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
- NOT APPLICABLE
Narratives
Additional Manufacturer Narrative · 1
CATHETER.
Description of Event or Problem · 1
THE CATHETER WAS KINKED AT THE PUMP SITE. THE CATHETER WAS REPLACED. NO PATIENT SYMPTOMS WERE REPORTED. THE TYPE OF MEDICATION, CONCENTRATION, AND DAILY DOSE BEING ADMINISTERED VIA THE PUMP WERE NOT REPORTED. ADDITIONAL INFO HAS BEEN REQUESTED, A FOLLOW-UP REPORT WILL BE SENT IF ADDITIONAL INFO BECOMES AVAILABLE.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | UNKNOWN PUMP | LKK | MEDTRONIC NEUROMODULATION | PUMP | NA |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Required Intervention | PROGRAMMER MODEL PROGRAMMER LOT# UNKNOWN| EXPLANTED| CATHETER MODEL 8709 LOT# UNK| IMPLANTED |