FDA Adverse Event
Injury
Summary report: N
6000032-2011-06430
MDR report key: 2332157
·
Received November 10, 2011
Report
- Report Number
- 6000032-2011-06430
- Event Type
- Injury
- Date Received
- November 10, 2011
- Report Date
- November 1, 2024
- Manufacturer
- MDT PUERTO RICO OPERATIONS CO, MED REL
- PMA / PMN Number
- P840001
- Adverse Event
- Yes
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- NY, US
- Reporter Occupation
- PHYSICIAN
- Health Professional
- Yes
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | NA | Male | Required Intervention | EXPLANTED| EXPLANTED| LEAD MODEL 3890 LOT# J0343741V IMPLANTED: | LEAD MODEL 3890 LOT# J0343742V, IMPLANTED |