FDA Adverse Event
Injury
Summary report: N
UNKNOWN IMPLANTABLE PUMP
MDR report key: 3162299
·
Received June 11, 2013
Report
- Report Number
- 3007566237-2013-01920
- Event Type
- Injury
- Date Received
- June 11, 2013
- Report Date
- May 17, 2013
- 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
(B)(4).
Description of Event or Problem · 1
A REPRESENTATIVE REPORTED THAT A PUMP WITH A PENDING ALARM WAS IMPLANTED AND ¿THEY HAD TO EXPLANT¿. THIS WAS NOTED TO HAVE OCCURRED OVER A YEAR AGO. THE MEDICATION USED WITHIN THE SYSTEM WAS UNKNOWN.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 262700 | UNKNOWN IMPLANTABLE PUMP | PUMP, INFUSION, IMPLANTED, PROGRAMMABLE | LKK | MEDTRONIC NEUROMODULATION | NEU_UNKNOWN_PUMP |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Required Intervention |