FDA Adverse Event
Injury
Summary report: N
ITREL II
MDR report key: 1327899
·
Received February 27, 2009
Report
- Report Number
- 6000032-2009-01398
- Event Type
- Injury
- Date Received
- February 27, 2009
- Report Date
- February 5, 2009
- Manufacturer
- MDT SOFAMOR DANEK PUERTO RICO MFG
- Product Code
- LGW
- PMA / PMN Number
- P840001
- Adverse Event
- Yes
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- IL, US
- Reporter Occupation
- NOT APPLICABLE
Narratives
Additional Manufacturer Narrative · 1
PRODUCT ID: 7495-66, SERIAL# (B)(4), IMPLANTED: (B)(6) 1993, EXPLANTED: (B)(6) 2001, PRODUCT TYPE: EXTENSION. PRODUCT ID: 3888-28, LOT# UNKNOWN, IMPLANTED: (B)(6) 1993, PRODUCT TYPE: LEAD. CONCLUSION CODES AND DEVICE CODES HAVE BEEN UPDATED TO THE FOLLOWING: (B)(4).
Description of Event or Problem · 1
IT WAS REPORTED THAT THE PATIENT HAD UNDERGONE THREE REVISIONS. NO PATIENT SYMPTOMS WERE REPORTED. THE DETAILS OF THE REVISION WERE NOT REPORTED. ADDITIONAL INFORMATION HAS BEEN REQUESTED, BUT WAS NOT AVAILABLE AS OF THE DATE OF THIS REPORT. REFERENCE MFR REPORT #6000032-2009-01399, 6000032-2009-01400.
Description of Event or Problem · 1
ADDITIONAL INFORMATION RECEIVED REPORTED THE PATIENT'S WIRES BROKE 10-12 YEARS AGO.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | ITREL II | LGW | MDT SOFAMOR DANEK PUERTO RICO MFG | 7424 | NA |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 61 YR | Required Intervention | LEAD: MODEL 3888, LOT# UNKNOWN| EXTENSION: MODEL 7495, LOT# XS0001319N| IMPLANTED:| EXPLATNED:| EXPLANTED:| IMPLANTED: |