FDA Adverse Event
Injury
Summary report: N
ITREL 3
MDR report key: 1911703
·
Received November 29, 2010
Report
- Report Number
- 3004209178-2010-09972
- Event Type
- Injury
- Date Received
- November 29, 2010
- Date of Event
- September 9, 2002
- Report Date
- November 16, 2010
- 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
- MA, US
- Reporter Occupation
- NOT APPLICABLE
Narratives
Additional Manufacturer Narrative · 1
(B)(4).
Additional Manufacturer Narrative · 1
(B)(4).
Description of Event or Problem · 1
ADDITIONAL REVIEW DETERMINED THIS EVENT WAS ALSO REPORTED IN MANUFACTURER REPORT #6000032-2013-00117. ANY ADDITIONAL INFORMATION RECEIVED REGARDING THIS EVENT WILL BE REPORTED UNDER THIS MANUFACTURING REPORT NUMBER. MANUFACTURER REPORT #6000032-2013-00117 ALSO INCLUDED A STATEMENT THAT ¿THE DEVICE HAD NOT WORKED FOR MANY YEARS AND IT WAS STILL IN THE PATIENT. THE PATIENT STILL HAS LOTS OF PAIN IN LEFT LEG AND FOOT¿; HOWEVER, ADDITIONAL REVIEW DETERMINED THAT INFORMATION DOES NOT PERTAIN TO THIS EVENT OR DEVICE.
Description of Event or Problem · 1
IT WAS STATED THAT THE DEVICE FAILED, THAT IT "BLEW A FUSE OR SOMETHING." IT WAS REPLACED. FURTHER INFO IS BEING REQUESTED AT THIS TIME.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | ITREL 3 | LGW | MDT SOFAMOR DANEK PUERTO RICO MFG | 7425 | NA |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 52 YR | Required Intervention | IMPLANTED:| EXTENSION: MODEL 7495-25, LOT# NAF018123N| IMPLANTED:| EXPLANTED:| EXPLANTED:| PROGRAMMER: MODEL 7434, LOT# YN0045801P| LEAD: MODEL 3887, LOT# J0019926V |