FDA Adverse Event
Injury
Summary report: N
RESTORE ULTRA
MDR report key: 1760489
·
Received July 15, 2010
Report
- Report Number
- 3004209178-2010-05528
- Event Type
- Injury
- Date Received
- July 15, 2010
- Date of Event
- June 21, 2010
- Report Date
- June 21, 2010
- Manufacturer
- MDT PUERTO RICO OPERATIONS CO., JUNCOS
- Product Code
- LGW
- PMA / PMN Number
- P840001
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- TX, US
- Reporter Occupation
- NOT APPLICABLE
Narratives
Additional Manufacturer Narrative · 1
(B)(4).
Description of Event or Problem · 1
SEE ALSO MANUFACTURER REPORT #3004209178-2010-05527. IT WAS REPORTED THAT THE PT EXPERIENCED AN INFECTION WITH THE FOLLOWING SYMPTOMS: "BURNING SENSATION, ACUTE PAIN, AND SWELLING." THE LOCATION OF THE PT'S SYMPTOMS WAS AT THE INS LOCATION. THE SYMPTOMS OCCURRED FOLLOWING AN IMPLANTATION. THE PT WAS ADMITTED TO THE HOSPITAL IN "SERIOUS" CONDITION. IT WAS UNCLEAR WHETHER THE NOTED PT SYMPTOMS OCCURRED AT ONE OR BOTH INS LOCATIONS, OR WHICH INS WAS INVOLVED.
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 | 32 YR | Hospitalization| R | EXPLANTED:| EXPLANTED:| IMPLANTED:| LEAD: MODEL 3777, LOT# V416733006| EXPLANTED:| IMPLANTED:| EXPLANTED:| EXPLANTED:| EXPLANTED:| IMPLANTED:| IMPLANTED:| IMPLANTED:| IMPLANTABLE NEURO STIMULATOR: MODEL 37712| LEAD: MODEL 3777, LOT# V468863019| LOT# NKF719421H| IMPLANTED:| ACCESSORY: MODEL 37752, LOT# NKA139023N| PROGRAMMER: MODEL 37743, LOT# NKE141505N| LEAD: MODEL 39565-65, LOT# V385006016 |