FDA Adverse Event
Injury
Summary report: N
RESTORE ADVANCED
MDR report key: 2832504
·
Received November 14, 2012
Report
- Report Number
- 3004209178-2012-10278
- Event Type
- Injury
- Date Received
- November 14, 2012
- Report Date
- October 16, 2012
- Manufacturer
- MEDTRONIC MED REL MEDTRONIC PUERTO RICO
- Product Code
- LGW
- PMA / PMN Number
- P840001
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- WI, US
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
PRODUCT ID, 3777-60 LOT# SERIAL# (B)(4), IMPLANTED: 2012 (B)(6), PRODUCT TYPE LEAD PRODUCT ID, 3777-60 LOT# SERIAL# (B)(4), PRODUCT TYPE LEAD PRODUCT ID, 37752 LOT# SERIAL# (B)(4). PRODUCT TYPE RECHARGER PRODUCT ID, 37743 LOT# SERIAL# (B)(4), PRODUCT TYPE PROGRAMMER, PATIENT. (B)(4).
Description of Event or Problem · 1
IT WAS REPORTED THAT THE PATIENT "SUFFERED" FROM AN INFECTION. IT WAS INDICATED THAT THE INFECTION BEGAN (B)(6) 2011, BUT THE TIME FRAME IS UNCERTAIN. IT WAS STATED THAT THE HEALTH CARE PROVIDER (HCP) DECIDED TO REVISE THE ENTIRE SYSTEM AFTER THE INFECTION ISSUE. IT WAS NOTED THAT AT ONE POINT THE PATIENT'S BLOOD SODIUM LEVELS WERE "NOT NORMAL." ADDITIONAL INFORMATION WAS REQUESTED AND IF RECEIVED, A SUPPLEMENTAL REPORT WILL BE SENT.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | RESTORE ADVANCED | STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF | LGW | MEDTRONIC MED REL MEDTRONIC PUERTO RICO | 37713 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Required Intervention |