FDA Adverse Event
Malfunction
Summary report: N
RESTORE PRIME
MDR report key: 2972082
·
Received February 21, 2013
Report
- Report Number
- 3004209178-2013-02945
- Event Type
- Malfunction
- Date Received
- February 21, 2013
- Report Date
- February 5, 2013
- 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
- MI, US
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
PRODUCT ID 377775, LOT # V009047, IMPLANTED: (B)(6) 2006, EXPLANTED: (B)(6) 2008, PRODUCT TYPE LEAD; PRODUCT ID 3708340, SERIAL # (B)(4), IMPLANTED: (B)(6) 2006, EXPLANTED: (B)(6) 2008, PRODUCT TYPE EXTENSION; PRODUCT ID 3487A-33, LOT # V005108, IMPLANTED: (B)(6) 2006, EXPLANTED: (B)(6) 2008, PRODUCT TYPE LEAD. (B)(4).
Additional Manufacturer Narrative · 1
(B)(4).
Description of Event or Problem · 1
IT WAS REPORTED THAT THE PATIENT WAS INFORMED SHE HAD NO LEADS "FUNCTIONING." NO FURTHER INFORMATION WAS REPORTED. ADDITIONAL INFORMATION HAS BEEN REQUESTED BUT WAS NOT AVAILABLE AS OF THE DATE OF THIS REPORT.
Description of Event or Problem · 1
ADDITIONAL INFORMATION REPORTED THE PATIENT HAD A LOT OF PAIN AND ¿THEIR LEG WOULD BE GONE.¿
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 75687 | RESTORE PRIME | STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF | LGW | MEDTRONIC MED REL MEDTRONIC PUERTO RICO | 37701 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |