FDA Adverse Event
Injury
Summary report: N
RESTORE PRIME ADVANCED
MDR report key: 2082810
·
Received May 3, 2011
Report
- Report Number
- 3004209178-2011-03216
- Event Type
- Injury
- Date Received
- May 3, 2011
- Date of Event
- January 1, 2010
- Report Date
- April 18, 2011
- Manufacturer
- MDT PUERTO RICO OPERATIONS CO., JUNCOS
- Product Code
- LGW
- PMA / PMN Number
- P840001
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- PA, US
- Reporter Occupation
- PHYSICIAN
Narratives
Additional Manufacturer Narrative · 1
(B)(4).
Description of Event or Problem · 1
INFO FROM THE PT'S HEALTH CARE PROVIDER (HCP) SHOWED THE PT HAD THEIR DEVICE AND THE LEADS REPOSITIONED ON (B)(6) 2010. IT WAS ALSO STATED THAT, AFTERWARD, THE PT ELECTED TO CANCEL F/U CARE WITH THEIR HCP. NO MORE INFO WAS AVAILABLE AT THE TIME OF THIS REPORT.
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 | 47 YR | Required Intervention | IMPLANTED:| EXPLANTED:| PROGRAMMER: MODEL 37743, LOT# NKE147517N| LEAD: MODEL 39565-65, LOT# V409876004| IMPLANTED:| EXPLANTED: |