FDA Adverse Event
Injury
Summary report: N
ITREL 3
MDR report key: 1253153
·
Received December 5, 2008
Report
- Report Number
- 6000032-2008-08032
- Event Type
- Injury
- Date Received
- December 5, 2008
- Report Date
- November 14, 2008
- Manufacturer
- MDT PUERTO RICO OPERATIONS CO, MED REL
- Product Code
- LGW
- PMA / PMN Number
- P840001
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- MO, US
- Reporter Occupation
- NOT APPLICABLE
Narratives
Description of Event or Problem · 1
IT WAS INITIALLY REPORTED THE PT'S DEVICE WAS FLIPPING IN THE POCKET AND CAUSING DISCOMFORT. THE PT HAD LOST 80 LBS CAUSING THE POCKET TO BE LOOSE. ADDITIONAL INFO RECEIVED INDICATED THE INS, LEAD AND EXTENSION WERE EXPLANTED DUE TO THE INS ISSUE. THE PT SYMPTOMS WERE REPORTED AS PRE-EXISTING PAIN. THE PHYSICIAN REPORTED THE PT'S OUTCOME AS NO INJURY.
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 | Required Intervention | EXPLANTED:| IMPLANTED:| LEAD MODEL 3887| EXPLANTED:| PROGRAMMER MODEL 7434| EXTENSION MODEL 7495-51| IMPLANTED: |