FDA Adverse Event
Injury
Summary report: N
RESTORE
MDR report key: 4003525
·
Received August 12, 2014
Report
- Report Number
- 3004209178-2014-15175
- Event Type
- Injury
- Date Received
- August 12, 2014
- Report Date
- July 22, 2014
- Manufacturer
- MEDTRONIC MED REL MEDTRONIC PUERTO RICO
- Product Code
- LGW
- PMA / PMN Number
- P840001
- Adverse Event
- Yes
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- TX, US
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
CONCOMITANT PRODUCTS: PRODUCT ID 377860, LOT # V011672, IMPLANTED: (B)(6) 2006, EXPLANTED: (B)(6) 2013, PRODUCT TYPE LEAD; PRODUCT ID 377860, LOT # V011672, IMPLANTED: (B)(6) 2006, EXPLANTED: (B)(6) 2013, PRODUCT TYPE LEAD. (B)(4).
Description of Event or Problem · 1
IT WAS REPORTED THE PATIENT EXPERIENCED A JOLTING SENSATION WHEN THEIR DEVICE WAS OFF. IT WAS NOTED THE ISSUE OCCURRED ONCE OR TWICE A NIGHT, ONCE OR TWICE A MONTH. IT WAS REPORTED A BAD LEAD WAS THE CAUSE AND THE ENTIRE SYSTEM WAS REPLACED. IT WAS NOTED THE REPLACEMENT WAS A YEAR AFTER THE START OF THE JOLTING.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 479885 | RESTORE | STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF | LGW | MEDTRONIC MED REL MEDTRONIC PUERTO RICO | 37711 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 00069 YR | Required Intervention |