FDA Adverse Event
Injury
Summary report: N
RESTORE ULTRA
MDR report key: 2073593
·
Received April 26, 2011
Report
- Report Number
- 3004209178-2011-03104
- Event Type
- Injury
- Date Received
- April 26, 2011
- Date of Event
- January 1, 2009
- Report Date
- April 8, 2011
- Manufacturer
- MDT PUERTO RICO OPERATIONS CO., JUNCOS
- Product Code
- LGW
- PMA / PMN Number
- P840001
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- CA, US
- Reporter Occupation
- PHYSICIAN
Narratives
Additional Manufacturer Narrative · 1
(B)(4).
Description of Event or Problem · 1
IT WAS REPORTED BY THE PT HEALTH CARE PROVIDER (HCP) THAT, FOLLOWING AN IMPLANT PROCEDURE, THE PT DEVELOPED PNEUMONITIS FROM ASPIRATION PNEUMONIA. THE PT WAS HOSPITALIZED, STABILIZED AND RELEASED. THE PT RECOVERED WITHOUT SEQUELA.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | RESTORE ULTRA | LGW | MDT PUERTO RICO OPERATIONS CO., JUNCOS | 37712 | NA |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 71 YR | Hospitalization | EXPLANTED:| EXTENSION: MODEL 7489, LOT# NHU126754V| IMPLANTED:| EXPLANTED:| LEAD: MODEL 3887, LOT# J0454930V| EXPLANTED:| PROGRAMMER: MODEL 37743, LOT# NKE133511N| IMPLANTED:| EXPLANTED:| ACCESSORY: MODEL 37752, LOT# NKA130853N| EXTENSION: MODEL 7489, LOT# NHU126755V| EXPLANTED:| IMPLANTED:| LEAD: MODEL 3887, LOT# V004177| IMPLANTED:| IMPLANTED:| IMPLANTED:| EXPLANTED: |