FDA Adverse Event
Malfunction
Summary report: N
RESTORE PRIME ADVANCED
MDR report key: 2152363
·
Received June 22, 2011
Report
- Report Number
- 3004209178-2011-04662
- Event Type
- Malfunction
- Date Received
- June 22, 2011
- Report Date
- May 25, 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
- IN, US
- Reporter Occupation
- NOT APPLICABLE
Narratives
Additional Manufacturer Narrative · 1
(B)(4).
Description of Event or Problem · 1
THE PT EXPERIENCED SPASMS IN HER FEET AND PELVIS. THE DEVICE HELPED WITH THOSE SPASMS. SHE HAD AN X-RAY AND THE DEVICE SYSTEM TURNED UP ON ITS OWN. ADD'L INFO HAS BEEN REQUESTED.
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 | EXPLANTED:| PROGRAMMER: MODEL 37743, LOT # NKE134157N| IMPLANTED:| LEAD: MODEL 3778, LOT # V328773031 |