FDA Adverse Event
Injury
Summary report: N
PUMP, INFUSION, IMPLANTED, PROGRAMMABLE
MDR report key: 7072365
·
Received November 30, 2017
Report
- Report Number
- 3007566237-2017-05013
- Event Type
- Injury
- Date Received
- November 30, 2017
- Report Date
- November 30, 2017
- Manufacturer
- MEDTRONIC NEUROMODULATION
- Product Code
- LKK
- PMA / PMN Number
- P860004
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- PA, US
- Reporter Occupation
- PHYSICIAN
Narratives
Additional Manufacturer Narrative · 1
IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.
Description of Event or Problem · 1
INFORMATION WAS RECEIVED FROM A HEALTHCARE PROVIDER REGARDING A PATIENT RECEIVING UNKNOWN BACLOFEN VIA AN IMPLANTED PUMP. IT WAS REPORTED A HOME PUMP REFILL NURSE NOTED THEY HAD SEEN A FEW OTHER CASES IN WHICH THE PATIENT'S EXPERIENCED BACLOFEN WITHDRAWAL FOLLOWING PUMP REFILLS.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 851359 | PUMP, INFUSION, IMPLANTED, PROGRAMMABLE | LKK | MEDTRONIC NEUROMODULATION | NEU_UNKNOWN_PUMP |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |