FDA Adverse Event
Malfunction
Summary report: N
ITREL 3
MDR report key: 1506738
·
Received October 1, 2009
Report
- Report Number
- 6000032-2009-06987
- Event Type
- Malfunction
- Date Received
- October 1, 2009
- Date of Event
- September 3, 2009
- Report Date
- September 3, 2009
- Manufacturer
- MDT PUERTO RICO OPERATIONS CO, MED REL
- Product Code
- LGW
- PMA / PMN Number
- P840001
- Adverse Event
- Yes
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- US
- Reporter Occupation
- UNKNOWN
Narratives
Additional Manufacturer Narrative · 1
(B) (4).
Description of Event or Problem · 1
THE PT EXPERIENCED A SHOCKING OR JOLTING SENSATION IN HIS ARMS, FACE AND SHOULDERS DURING A MAGNETIC RESONANCE IMAGING OF THE HEAD. THE MAGNETIC RESONANCE IMAGING STRENGTH WAS 1.5 TESLA, BUT WAS NOT A TRANSMIT AND RECEIVE COIL. THE PT'S SHOCKING SENSATION SUBSIDED AND HE WAS FEELING OK. PLEASE REFERENCE MFG. REPORT # 6000032-2009-06988. IT IS UNCLEAR WHICH SYSTEM WAS INVOLVED AND IT IS UNCLEAR WHICH SYSTEM COMPONENTS STILL REMAIN IMPLANTED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | ITREL 3 | LGW | MDT PUERTO RICO OPERATIONS CO, MED REL | 7425 | NA |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 54 YR | EXPLANTED:| LEAD: MODEL 3587A, LOT# L49929| EXTENSION: MODEL 7495-51, LOT# XR0033284N| LEAD: MODEL 3487A, LOT# L54147| LOT # NAT002957H| IMPLANTABLE NEURO STIMULATOR: MODEL 7425| EXPLANTED:| PROGRAMMER: MODEL PROGRAMMER, LOT# UNK| EXPLANTED:| IMPLANTED:| EXTENSION: MODEL 7495-51, LOT# XR0049662N| IMPLANTED:| EXPLANTED:| IMPLANTED:| IMPLANTED| IMPLANTED:| EXPLANTED:| IMPLANTED: |