FDA Adverse Event
Malfunction
Summary report: N
INDURA
MDR report key: 903171
·
Received August 24, 2007
Report
- Report Number
- 2182207-2007-02720
- Event Type
- Malfunction
- Date Received
- August 24, 2007
- Date of Event
- July 30, 2007
- Report Date
- July 30, 2007
- Manufacturer
- MEDTRONIC NEUROMODULATION
- Product Code
- LKK
- PMA / PMN Number
- P860004
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- JA
- Reporter Occupation
- PHYSICIAN
Narratives
Additional Manufacturer Narrative · 1
.
Description of Event or Problem · 1
THE PHYSICIAN REPORTED THAT DURING A PUMP ROLLER TEST, AN ANOMALY RATE WAS DETECTED. ADD'L INFO RECEIVED SHOWS A CATHETER KINK WAS SUSPECTED FROM X-RAY RESULTS; A REVISION WAS ANTICIPATED TO CONFIRM THE CATHETER STATUS. THE DRUG USED IN THE PUMP WAS BACLOFEN. THE PUMP STATUS WAS REPORTED AS STILL IN USE. ADD'L INFO HAS BEEN REQUESTED. REFER TO MFR REPORT #6000030-2007-02719.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | INDURA | LKK | MEDTRONIC NEUROMODULATION | 8711 | UNK |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 36 YR | Required Intervention |