FDA Adverse Event
Malfunction
Summary report: N
INDURA CATHETER
MDR report key: 5386137
·
Received January 22, 2016
Report
- Report Number
- 3007566237-2016-00387
- Event Type
- Malfunction
- Date Received
- January 22, 2016
- Report Date
- December 30, 2015
- 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: 8637-20, SERIAL# (B)(4), IMPLANTED:(B)(6) 2009, PRODUCT TYPE: PUMP. PRODUCT ID: 8709, LOT# J0058218R, IMPLANTED: (B)(6) 2001, PRODUCT TYPE: CATHETER. (B)(4).
Description of Event or Problem · 1
THE 8709SC CATHETER WAS RETURNED TO THE MANUFACTURER AND UNDERWENT ROUTINE ANALYSIS. REFER TO MFR. REPORT NUMBER 3004209178-2015-16373 FOR ASSOCIATED 8637-20 PUMP EVENT WHICH LED TO THE CATHETER RETURN.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 43773 | INDURA CATHETER | PUMP, INFUSION, IMPLANTED, PROGRAMMABLE | LKK | MEDTRONIC NEUROMODULATION | 8709SC |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 00056 YR |