FDA Adverse Event
Injury
Summary report: N
PUMP, INFUSION, IMPLANTED, PROGRAMMABLE
MDR report key: 3203489
·
Received July 2, 2013
Report
- Report Number
- 3007566237-2013-01060
- Event Type
- Injury
- Date Received
- July 2, 2013
- Date of Event
- August 13, 2012
- Report Date
- August 13, 2012
- Manufacturer
- MEDTRONIC NEUROMODULATION
- Product Code
- LKK
- PMA / PMN Number
- P860004
- Adverse Event
- Yes
- 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, IMPLANTED: (B)(6) 2003. PRODUCT TYPE: CATHETER. (B)(4).
Description of Event or Problem · 1
IT WAS REPORTED THAT THE PUMP HAD A MOTOR STALL. THE PUMP WAS REPLACED. THE PUMP WAS REPORTED TO HAVE BEEN RETURNED TO THE MANUFACTURER AND FOUND TO BE CORRODED. THE SERIAL NUMBER OF THE PUMP WAS NOT REPORTED SO THIS COULD NOT BE CONFIRMED. THE PATIENT HAD NOT HAD ANY PROBLEMS SINCE THE PUMP REPLACEMENT.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 302802 | PUMP, INFUSION, IMPLANTED, PROGRAMMABLE | LKK | MEDTRONIC NEUROMODULATION | NEU_UNKNOWN_PUMP |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Required Intervention |