FDA Adverse Event
Malfunction
Summary report: N
UNKNOWN IMPLANTABLE PUMP
MDR report key: 4220724
·
Received November 3, 2014
Report
- Report Number
- 3007566237-2014-03210
- Event Type
- Malfunction
- Date Received
- November 3, 2014
- Report Date
- October 7, 2014
- Manufacturer
- MEDTRONIC NEUROMODULATION
- Product Code
- LKK
- PMA / PMN Number
- P860004
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- IL, US
- Reporter Occupation
- PHYSICIAN
Narratives
Additional Manufacturer Narrative · 1
CONCOMITANT PRODUCT: PRODUCT ID NEU_UNKNOWN_CATH, SERIAL # UNKNOWN, PRODUCT TYPE CATHETER. (B)(4).
Description of Event or Problem · 1
IT WAS REPORTED THAT ¿IN MOST CASES WHERE THERE IS ABNORMAL VOLUME FOUND IN THE PUMP, IT IS RELATED TO NOT BEING REFILLED PROPERLY OR SOME OF THE DRUG MAY HAVE ESCAPED AT THE TIME OF THE REFILL.¿ NO FURTHER INFORMATION RELATED TO THIS INFORMATION WAS PROVIDED. ADDITIONAL INFORMATION HAS BEEN REQUESTED BUT WAS NOT AVAILABLE AS OF THE DATE OF THIS REPORT. A FOLLOW-UP REPORT WILL BE SUBMITTED IF ADDITIONAL INFORMATION IS RECEIVED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 701407 | UNKNOWN IMPLANTABLE PUMP | PUMP, INFUSION, IMPLANTED, PROGRAMMABLE | LKK | MEDTRONIC NEUROMODULATION | NEU_UNKNOWN_PUMP |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |