FDA Adverse Event
Malfunction
Summary report: N
PUMP, INFUSION, IMPLANTED, PROGRAMMABLE
MDR report key: 4130922
·
Received September 30, 2014
Report
- Report Number
- 3007566237-2014-02788
- Event Type
- Malfunction
- Date Received
- September 30, 2014
- Date of Event
- August 24, 2014
- Report Date
- August 24, 2014
- Manufacturer
- MEDTRONIC NEUROMODULATION
- Product Code
- LKK
- PMA / PMN Number
- P860004
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- MN, US
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
CONCOMITANT MEDICAL PRODUCTS: PRODUCT ID NEU_UNKNOWN_CATH, SERIAL# UNKNOWN, PRODUCT TYPE: CATHETER. (B)(4).
Additional Manufacturer Narrative · 1
(B)(4)
Description of Event or Problem · 1
ALL PREVIOUSLY REPORTED INFORMATION IN THIS MANUFACTURER REPORT WAS ALREADY REPORTED IN THE FOLLOWING MANUFACTURER REPORTS. ANY SUPPLEMENTAL INFORMATION REGARDING THE PREVIOUSLY REPORTED MOTOR STALLS WILL BE SUBMITTED VIA THESE REPORTS: 3004209178-2014-15833 3004209178-2014-15990.
Description of Event or Problem · 1
IT WAS REPORTED THERE 3 OR 4 PUMPS WITH MOTOR STALLS IN THE LAST MONTH. ALL HAD BEEN WITH OFF-LABEL DRUGS. NO PATIENT INFORMATION OR OUTCOMES WERE REPORTED. A SUPPLEMENTAL REPORT WILL BE SUBMITTED IF ADDITIONAL INFORMATION BECOMES AVAILABLE.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 607005 | PUMP, INFUSION, IMPLANTED, PROGRAMMABLE | LKK | MEDTRONIC NEUROMODULATION | NEU_UNKNOWN_PUMP |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |