FDA Adverse Event
Injury
Summary report: N
RESTORE ULTRA
MDR report key: 1910493
·
Received November 18, 2010
Report
- Report Number
- 3004209178-2010-09783
- Event Type
- Injury
- Date Received
- November 18, 2010
- Date of Event
- November 1, 2010
- Report Date
- November 11, 2010
- Manufacturer
- MDT PUERTO RICO OPERATIONS CO., JUNCOS
- Product Code
- LGW
- PMA / PMN Number
- P840001
- Adverse Event
- Yes
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- IN, US
- Reporter Occupation
- NOT APPLICABLE
- Health Professional
- N
Narratives
Additional Manufacturer Narrative · 1
(B)(4).
Description of Event or Problem · 1
IT WAS REPORTED THE PT EXPERIENCE POSSIBLE INFECTION SYMPTOMS. THE PT'S LEFT HIP AT THE SITE OF THE DEVICE WAS VERY PAINFUL, LUMPY, AND WHEN SHE WALKED IT GOT MORE SWOLLEN. IT WAS ALSO PAINFUL WHEN SHE GOT UP AND SAT DOWN. THE PT WAS AT HOME WAITING FOR THE HEALTHCARE PROVIDER (HCP) TO RETURN HER PHONE CALL. THE PT STATED SHE WOULD GO TO THE EMERGENCY ROOM IF SHE DID NOT HEAR BACK FROM THE HCP SOON. ADD'L INFO HAS BEEN REQUESTED; A FOLLOW-UP REPORT WILL BE SUBMITTED IF ADD'L INFO BECOMES AVAILABLE.
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 | 70 YR | Female | Required Intervention| O | ACCESSORY: MODEL 37752, LOT# NKA142486N| EXPLANTED:| IMPLANTED:| LEAD: MODEL 39565-65, LOT# V516608041| PROGRAMMER: MODEL 37743, LOT# NKE150145N| ACCESSORY: MODEL 37752, LOT# NKA142486N| EXPLANTED:| IMPLANTED:| LEAD: MODEL 39565-65, LOT# V516608041| PROGRAMMER: MODEL 37743, LOT# NKE150145N |