FDA Adverse Event
Malfunction
Summary report: N
UNKNOWN IMPLANTABLE PUMP
MDR report key: 3624599
·
Received February 12, 2014
Report
- Report Number
- 3007566237-2014-00452
- Event Type
- Malfunction
- Date Received
- February 12, 2014
- Report Date
- January 23, 2014
- Manufacturer
- MEDTRONIC NEUROMODULATION
- Product Code
- LKK
- PMA / PMN Number
- P860004
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- MN, US
- Reporter Occupation
- PHYSICIAN
Narratives
Additional Manufacturer Narrative · 1
CONCOMITANT MEDICAL PRODUCTS: PRODUCT ID: NEU_UNKNOWN_CATH, PRODUCT TYPE: CATHETER. (B)(4).
Additional Manufacturer Narrative · 1
(B)(4).
Description of Event or Problem · 1
IT WAS REPORTED THAT THE HEALTH CARE PROVIDER (HCP) HAS HAD OTHER PUMPS WITH RESETS OCCURRING. NO FURTHER INFORMATION WAS PROVIDED. ADDITIONAL INFORMATION HAS BEEN REQUESTED, BUT WAS NOT AVAILABLE AS OF THE DATE OF THIS REPORT.
Description of Event or Problem · 1
ADDITIONAL INFORMATION RECEIVED REPORTED THAT THE TYPES OF PUMP RESETS WERE FROM STALLED MOTORS, ¿PREMATURE FROM 1-2 YEARS¿, FROM CORROSION. IT WAS REPORTED THAT THE PUMPS DID NOT GO INTO SAFE RATE AFTER THE RESETS AND THAT THE DEVICE/PATIENT INFORMATION WAS NOT AVAILABLE.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 92119 | UNKNOWN IMPLANTABLE PUMP | PUMP, INFUSION, IMPLANTED, PROGRAMMABLE | LKK | MEDTRONIC NEUROMODULATION | NEU_UNKNOWN_PUMP |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |