FDA Adverse Event
Injury
Summary report: N
RESTORE ULTRA
MDR report key: 3953557
·
Received July 23, 2014
Report
- Report Number
- 3004209178-2014-13439
- Event Type
- Injury
- Date Received
- July 23, 2014
- Report Date
- July 2, 2014
- Manufacturer
- MEDTRONIC MED REL MEDTRONIC PUERTO RICO
- Product Code
- LGW
- PMA / PMN Number
- P840001
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- PA, US
- Reporter Occupation
- PHYSICIAN
Narratives
Additional Manufacturer Narrative · 1
ANALYSIS OF THE INS MODEL 37712, SERIAL NUMBER (B)(4) FOUND NO SIGNIFICANT ANOMALIES.
Additional Manufacturer Narrative · 1
CONCOMITANT MEDICAL PRODUCTS: PRODUCT ID: 39565-65, SERIAL# (B)(4) IMPLANTED: (B)(6) 2010, PRODUCT TYPE: LEAD. PRODUCT ID: 37743, SERIAL# (B)(4), PRODUCT TYPE: PROGRAMMER, PATIENT. PRODUCT ID: 37752, SERIAL# (B)(4), PRODUCT TYPE: RECHARGER. (B)(4).
Additional Manufacturer Narrative · 1
IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.
Description of Event or Problem · 1
IT WAS REPORTED THAT THE PATIENT HAD SIGNIFICANT PAIN IN THEIR NECK WHEN THE STIMULATOR WAS ON. THE PATIENT ALSO NEVER HAD RELIEF WITH THE STIMULATOR. THERE WERE NO PATIENT INJURIES AND THE PATIENT RECOVERED WITHOUT SEQUELAE AFTER THE REMOVAL.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 429888 | RESTORE ULTRA | STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF | LGW | MEDTRONIC MED REL MEDTRONIC PUERTO RICO | 37712 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 00052 YR | Required Intervention |