FDA Adverse Event
Malfunction
Summary report: N
RESTORE ULTRA
MDR report key: 2182286
·
Received July 11, 2011
Report
- Report Number
- 3004209178-2011-05284
- Event Type
- Malfunction
- Date Received
- July 11, 2011
- Date of Event
- January 1, 2011
- Report Date
- June 16, 2011
- Manufacturer
- MEDTRONIC PUERTO RICO OPERATIONS CO., JUNCOS
- Product Code
- LGW
- PMA / PMN Number
- P840001
- Adverse Event
- Yes
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- FL, US
- Reporter Occupation
- UNKNOWN
Narratives
Additional Manufacturer Narrative · 1
(B)(4).
Description of Event or Problem · 1
THE PT EXPERIENCED PAIN ON HER RIGHT SIDE AND SPINE WHEN THE IMPLANTABLE NEUROSTIMULATOR WAS TURNED ON BECAUSE ONE OF THER LEADS HAD DISLODGED. SHE VISITED HER HEALTH CARE PROFESSIONAL ABOUT THE LEAD DISLODGEMENT AND HE RECOMMENDED A REVISION. ADD'L INFO HAS BEEN REQUESTED, A F/U REPORT WILL BE SENT IF ADD'L INFO BECOMES AVAILABLE.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | RESTORE ULTRA | LGW | MEDTRONIC PUERTO RICO OPERATIONS CO., JUNCOS | 37712 | NA |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 46 YR | LEAD: MODEL 3998, LOT #V055126| EXTENSION: MODEL 37082, LOT #NKB007395V| LEAD: MODEL 3487A, LOT #V499805| IMPLANTED:| EXPLANTED:| EXPLANTED:| EXPLANTED:| IMPLANTED:| EXPLANTED:| IMPLANTED:| EXTENSION: MODEL 37082, LOT #NKB007716N| ACCESSORY: MODEL 37752, LOT #NKA144298N| PROGRAMMER: MODEL 37743, LOT #NKE156057N| IMPLANTED: |