FDA Adverse Event
Malfunction
Summary report: N
IMPLANTABLE CATHETER
MDR report key: 3202739
·
Received July 2, 2013
Report
- Report Number
- 3007566237-2013-01234
- Event Type
- Malfunction
- Date Received
- July 2, 2013
- Report Date
- May 29, 2012
- Manufacturer
- MEDTRONIC NEUROMODULATION
- Product Code
- LKK
- PMA / PMN Number
- P860004
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- TX, US
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
(B)(4).
Description of Event or Problem · 1
IT WAS REPORTED THAT THE PUMP TRIAL WAS UNSUCCESSFUL BECAUSE THE PHYSICIAN WAS NOT ABLE TO INSERT THE CATHETER INTO THE SPINAL CANAL TO COMPLETE THE TRIAL. IT WAS REPORTED THAT HER SPINAL CANAL IS TOO NARROW AND THAT SHE HAS MANY SPINE ISSUES SUCH AS STENOSIS, SCOLIOSIS, DDD, AND SCAR TISSUE. THE TRIAL WAS UNSUCCESSFUL. THE PT IS LOOKING FOR ANOTHER PHYSICIAN TO HELP HER WITH A PUMP TRIAL.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 301841 | IMPLANTABLE CATHETER | PUMP, INFUSION, IMPLANTED, PROGRAMMABLE | LKK | MEDTRONIC NEUROMODULATION | NEU_UNKNOWN_CATH |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |