FDA Adverse Event
Injury
Summary report: N
ISOMED
MDR report key: 2938788
·
Received January 31, 2013
Report
- Report Number
- 3007566237-2013-00337
- Event Type
- Injury
- Date Received
- January 31, 2013
- Report Date
- January 15, 2013
- Manufacturer
- MEDTRONIC NEUROMODULATION
- Product Code
- LKK
- PMA / PMN Number
- P990034
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- SC, US
- Reporter Occupation
- HEALTH PROFESSIONAL
Narratives
Additional Manufacturer Narrative · 1
(B)(4).
Additional Manufacturer Narrative · 1
CATHETER MODEL: 8709, SERIAL# (B)(4), IMPLANTED: 2000-(B)(6), EXPLANTED: UNK; CONNECTOR MODEL: 8577 LOT# N082271, IMPLANTED: 2007-(B)(6), EXPLANTED: UNK. (B)(4).
Description of Event or Problem · 1
AN MRI WAS ORDERED TO RULE OUT AN I.M (INFLAMMATORY MASS). REPORTER HAD NO OTHER INFORMATION. DRUG DELIVERED VIA THE DEVICE WAS MORPHINE. ADDITIONAL INFORMATION HAS BEEN REQUESTED, BUT WAS NOT AVAILABLE AS OF THE DATE OF THIS REPORT.
Description of Event or Problem · 1
ADDITIONAL INFORMATION: IT WAS REPORTED THAT THE PATIENT HAD DIFFUSE COMPLAINTS. A MAGNETIC RESONANCE IMAGE (MRI) WAS DONE AND NO INTRATHECAL MASS WAS FOUND.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 42342 | ISOMED | PUMP, INFUSION, IMPLANTED, PROGRAMMABLE | LKK | MEDTRONIC NEUROMODULATION | 8472-35-05 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Other |