FDA Adverse Event
Malfunction
Summary report: N
RESTORE PRIME ADVANCED
MDR report key: 2081407
·
Received April 22, 2011
Report
- Report Number
- 3004209178-2011-03027
- Event Type
- Malfunction
- Date Received
- April 22, 2011
- Date of Event
- March 31, 2011
- Report Date
- April 1, 2011
- Manufacturer
- MDT PUERTO RICO OPERATIONS CO., JUNCOS
- Product Code
- LGW
- PMA / PMN Number
- P840001
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- MN, US
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
(B)(4).
Description of Event or Problem · 1
THE PT EXPERIENCED MUSCLE PAIN AND SPASMS IN THE BACK ON THE LEFT SIDE, GOING UP INTO HER CHEST AND INTO HER NECK. SHE ALSO EXPERIENCED A SHOCKING AND BURNING SENSATION IN THE UPPER BACK AREA AT THE LEAD/EXTENSION LOCATION. THE PT ALSO HAD SOME DIFFICULTY BREATHING. THERE WAS NO KNOWN TRAUMA, MEDICAL PROCEDURE, OR OTHER NOTABLE EVENT THAT STARTED THIS PAIN. SHE WENT TO THE EMERGENCY ROOM FOR THE PAIN. THE PT WAS DISCHARGED FROM THE ER WITH THE DEVICE OFF BUT SHE STILL EXPERIENCED THE BURNING SENSATION. ADDITIONAL INFORMATION WAS 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 | 58 YR | EXPLANTED:| PROGRAMMER: MODEL 37743, LOT# NKE104345N| IMPLANTED:| EXPLANTED:| LEAD: MODEL 3998, LOT# V296379| IMPLANTED:| IMPLANTED:| EXPLANTED:| EXTENSION: MODEL 37082, LOT# NKB012569N| EXPLANTED:| IMPLANTED:| LEAD: MODEL 3998, LOT# V014190| EXTENSION: MODEL 37082, LOT# NKB004757V |