FDA Adverse Event
Injury
Summary report: N
RESTORE
MDR report key: 3032943
·
Received April 3, 2013
Report
- Report Number
- 3004209178-2013-04536
- Event Type
- Injury
- Date Received
- April 3, 2013
- Report Date
- March 18, 2013
- Manufacturer
- MEDTRONIC MED REL MEDTRONIC PUERTO RICO
- Product Code
- LGW
- PMA / PMN Number
- P840001
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- OH, US
- Reporter Occupation
- PHYSICIAN
Narratives
Additional Manufacturer Narrative · 1
(B)(4).
Additional Manufacturer Narrative · 1
PRODUCT ID, 3777-75 LOT# SERIAL# (B)(4), IMPLANTED: 2009 (B)(6), PRODUCT TYPE LEAD; PRODUCT ID, 37752 LOT# SERIAL# (B)(4), PRODUCT TYPE RECHARGER; PRODUCT ID, 37743 LOT# SERIAL# (B)(4), PRODUCT TYPE PROGRAMMER, PATIENT; PRODUCT ID, 3777-75 LOT# SERIAL# (B)(4), IMPLANTED: 2009 (B)(6), PRODUCT TYPE LEAD. (B)(4).
Description of Event or Problem · 1
IT WAS INITIALLY REPORTED, THE PATIENT HAD A LEAD REVISION (SEE MANUFACTURER'S REPORT# 3004209178-2013-02992) AND THEN HAD A SPINAL HEADACHE FOR MANY DAYS. ADDITIONAL INFORMATION RECEIVED THE DAY OF REPORT REPORTED, THE PATIENT'S SPINAL HEADACHE WAS TREATED WITH A BLOOD PATCH AND IT HAD RESOLVED. THE DATE THE BLOOD PATCH WAS PERFORMED WAS NOT PROVIDED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 135763 | RESTORE | STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF | LGW | MEDTRONIC MED REL MEDTRONIC PUERTO RICO | 37711 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Required Intervention |