FDA Adverse Event
Malfunction
Summary report: N
PUMP, INFUSION, IMPLANTED, PROGRAMMABLE
MDR report key: 3961208
·
Received July 28, 2014
Report
- Report Number
- 3007566237-2014-02092
- Event Type
- Malfunction
- Date Received
- July 28, 2014
- Report Date
- June 30, 2014
- Manufacturer
- MEDTRONIC NEUROMODULATION
- Product Code
- LKK
- PMA / PMN Number
- P860004
- Removal / Correction Number
- Z-1060-2011
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- SZ
- Reporter Occupation
- HEALTH PROFESSIONAL
Narratives
Additional Manufacturer Narrative · 1
(B)(4).
Description of Event or Problem · 1
IT WAS REPORTED THAT 4-5 SMALL POCKET FILLINGS HAD OCCURRED IN THE LAST FEW YEARS. NO PATIENT SYMPTOMS WERE REPORTED AT THIS TIME AND IT WAS UNKNOWN WHAT MEDICATION THIS DEVICE SYSTEMS DELIVERED AT THE TIME OF THE EVENTS. ADDITIONAL INFORMATION HAS BEEN REQUESTED, BUT WAS NOT AVAILABLE AS OF THE DATE OF THIS REPORT.
Description of Event or Problem · 1
IT WAS FURTHER PROVIDED THAT THESE OTHER POCKET FILLS HAD NOT BEEN TRACKED BY THE HEALTH CARE PROVIDER AND NO FURTHER INFORMATION WAS AVAILABLE.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 439117 | PUMP, INFUSION, IMPLANTED, PROGRAMMABLE | LKK | MEDTRONIC NEUROMODULATION | NEU_UNKNOWN_PUMP |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |