FDA Adverse Event
Malfunction
Summary report: N
RESTORE ULTRA
MDR report key: 2081048
·
Received April 14, 2011
Report
- Report Number
- 3004209178-2011-02819
- Event Type
- Malfunction
- Date Received
- April 14, 2011
- Report Date
- March 25, 2011
- Manufacturer
- MDT PUERTO RICO OPERATIONS CO., JUNCOS
- Product Code
- LGW
- PMA / PMN Number
- P840001
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- NY, US
- Reporter Occupation
- NOT APPLICABLE
Narratives
Additional Manufacturer Narrative · 1
(B)(4).
Description of Event or Problem · 1
A LEAD MIGRATION WAS CONFIRMED BY DIAGNOSTICS TESTS. THE PT HAS NOT EXPERIENCED ANY SYMPTOMS. THERE WAS NO KNOWN ACCIDENT OR INCIDENT RELATED TO THIS COMPLAINT. HE WAS AT HOME IN GOOD CONDITION. ADDITIONAL INFO HAS BEEN REQUESTED.
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 | PROGRAMMER: MODEL 37743, LOT # NKE100758N| LEAD: MODEL 3778, LOT # V080487014| IMPLANTED:| IMPLANTED:| EXPLANTED:| LEAD: MODEL 3778, LOT # V113886020| EXPLANTED: |