FDA Adverse Event
Injury
Summary report: N
ITREL 3
MDR report key: 2160655
·
Received July 7, 2011
Report
- Report Number
- 3004209178-2011-05179
- Event Type
- Injury
- Date Received
- July 7, 2011
- Date of Event
- January 1, 2011
- Report Date
- May 26, 2011
- Manufacturer
- MDT PUERTO RICO OPERATIONS CO., JUNCOS
- Product Code
- LGW
- PMA / PMN Number
- P840001
- Adverse Event
- Yes
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- WY, US
- Reporter Occupation
- PHYSICIAN
Narratives
Additional Manufacturer Narrative · 1
(B)(4).
Description of Event or Problem · 1
THE PT HAD HIS IMPLANTABLE NEUROSTIMULATOR EXPLANTED BUT THE LEADS WERE CUT AND REMAINED IMPLANTED. THE REASON FOR THE EXPLANT WAS NOT PROVIDED. ONE HEALTH CARE PROFESSIONAL (HCP) REPORTED THE PT HAD AN MRI AND EXPERIENCED UNSPECIFIED NEUROLOGICAL DAMAGE THAT RESULTED IN (B)(6) OF DIFFICULTY SPEAKING. A SECOND HCP INDICATED THAT THE PT WAS PLACED ON THE MRI TABLE BUT THAT THE MRI MACHINE WAS NOT TURNED ON. THE PT EVENTUALLY FULLY RECOVERED. A FOLLOW-UP REPORT WILL BE SENT IF ADDITIONAL INFO BECOMES AVAILABLE. SEE ALSO MFR REPORT #3007566237-2011-05180.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | ITREL 3 | LGW | MDT PUERTO RICO OPERATIONS CO., JUNCOS | 7425 | NA |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 55 YR | Required Intervention | IMPLANTED:| EXTENSION: MODEL 7495-51, LOT# XR0033284N| LEAD: MODEL 3587A, LOT# L49929| IMPLANTED:| EXTENSION: MODEL 7495-51, LOT# XR0049662N| IMPLANTED:| LEAD: MODEL 3487A, LOT# L54147| EXPLANTED:| EXPLANTED:| LOT# NAT116266H| EXPLANTED:| EXPLANTED:| IMPLANTED:| IMPLANTABLE NEURO STIMULATOR: MODEL 7425,| EXPLANTED:| IMPLANTED: |