FDA Adverse Event
Injury
Summary report: N
RESTORE PRIME ADVANCED
MDR report key: 2052531
·
Received April 11, 2011
Report
- Report Number
- 3004209178-2011-02740
- Event Type
- Injury
- Date Received
- April 11, 2011
- Date of Event
- July 15, 2008
- Report Date
- March 23, 2011
- Manufacturer
- MDT PUERTO RICO OPERATIONS CO., JUNCOS
- Product Code
- LGW
- PMA / PMN Number
- P840001
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- FL, US
- Reporter Occupation
- PHYSICIAN
Narratives
Additional Manufacturer Narrative · 1
(B)(4).
Description of Event or Problem · 1
IT WAS REPORTED THE PT'S DEVICE WAS REMOVED DUE TO INFECTION ON (B)(6) 2008. DETAILS OF THE INFECTION WERE NOT REPORTED. THE PT RECOVERED WITHOUT SEQUELA.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | RESTORE PRIME ADVANCED | LGW | MDT PUERTO RICO OPERATIONS CO., JUNCOS | 37702 | NA |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 63 YR | Required Intervention | IMPLANTED:| LEAD: MODEL 3487A, LOT# V019422| LEAD: MODEL 3487A, LOT# V019422| EXTENSION: MODEL 37082, LOT# NKB004743N| EXPLANTED:| IMPLANTED:| IMPLANTED:| EXPLANTED:| EXPLANTED: |