FDA Adverse Event
Malfunction
Summary report: N
PUMP, INFUSION, IMPLANTED, PROGRAMMABLE
MDR report key: 3130736
·
Received May 24, 2013
Report
- Report Number
- 3007566237-2013-01752
- Event Type
- Malfunction
- Date Received
- May 24, 2013
- Report Date
- April 24, 2013
- Manufacturer
- MEDTRONIC NEUROMODULATION
- Product Code
- LKK
- PMA / PMN Number
- P860004
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- AR, US
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
(B)(4).
Description of Event or Problem · 1
IT WAS REPORTED THAT A PATIENT¿S CATHETER WAS TWISTED AND THUS THE PATIENT WAS NOT GETTING ANY MEDICINE. THE EVENT REPORTED WAS INFORMATION OVERHEARD BY THE REPORTER, THEREFORE THE PATIENT INFORMATION WAS UNKNOWN. ADDITIONAL INFORMATION HAS BEEN REQUESTED; BUT WAS NOT YET RECEIVED AS OF THE DATE OF REPORT. THE DRUG ON THE PUMP WAS UNKNOWN.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 231905 | PUMP, INFUSION, IMPLANTED, PROGRAMMABLE | LKK | MEDTRONIC NEUROMODULATION | NEU_UNKNOWN_PUMP |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | UNKNOWN NEURO CATHETER |