FDA Adverse Event
Injury
Summary report: N
RESTORE ULTRA
MDR report key: 2133528
·
Received June 15, 2011
Report
- Report Number
- 3004209178-2011-04468
- Event Type
- Injury
- Date Received
- June 15, 2011
- Date of Event
- October 15, 2009
- Report Date
- May 23, 2011
- 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
- TX, US
- Reporter Occupation
- PHYSICIAN
Narratives
Additional Manufacturer Narrative · 1
(B)(4).
Additional Manufacturer Narrative · 1
(B)(4).
Additional Manufacturer Narrative · 1
(B)(4).
Description of Event or Problem · 1
A LEAD MIGRATION WAS REPORTED, AS WELL AS LOSS OF THERAPEUTIC EFFECT TO THE RIGHT SIDE OF BODY. ON (B)(6) 2009, X-RAY INDICATED LEAD MIGRATION FROM T-9 TO T-10 TO T-12. THE LEADS WERE EXPLANTED AND REPLACED ON (B)(6) 2010. THE PT RECOVERED WITHOUT SEQUELAE.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | RESTORE ULTRA | STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF | LGW | MDT PUERTO RICO OPERATIONS CO., JUNCOS | 37712 | NA |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 47 YR | Required Intervention | IMPLANTED:| EXPLANTED:| EXPLANTED:| ACCESSORY: MODEL 37752, LOT # NKA122858N| IMPLANTED:| IMPLANTED:| STIM ACCESSORY: MODEL 3550-39, LOT # N188752| EXPLANTED:| IMPLANTED:| LEAD: MODEL 3778, LOT # V230574028| EXPLANTED:| IMPLANTED:| LEAD: MODEL 3778, LOT # V230574028| EXPLANTED:| LEAD: MODEL 3778, LOT # V232871023 |