FDA Adverse Event
Injury
Summary report: N
RESTORE SENSOR
MDR report key: 3082309
·
Received April 29, 2013
Report
- Report Number
- 3004209178-2013-06994
- Event Type
- Injury
- Date Received
- April 29, 2013
- Report Date
- April 11, 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
- MN, US
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
(B)(4).
Additional Manufacturer Narrative · 1
CONCOMITANT PRODUCT: PRODUCT ID 37754, SERIAL# (B)(4), PRODUCT TYPE RECHARGER; PRODUCT ID 37744, SERIAL# (B)(4), PRODUCT TYPE PROGRAMMER, PATIENT; PRODUCT ID 39286-65, SERIAL# (B)(4), IMPLANTED: (B)(6) 2012, PRODUCT TYPE LEAD; (B)(4).
Description of Event or Problem · 1
IT WAS REPORTED THE PATIENT HAD TROUBLE COUPLING USING THE RECHARGER WITH THE IMPLANTABLE NEUROSTIMULATOR (INS). THE PATIENT HAD 'A COUPLE' OF REVISIONS WHERE THE POCKET WAS REVISED. NO PATIENT SYMPTOMS WERE REPORTED. PATIENT OUTCOME WAS NOT PROVIDED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 183820 | RESTORE SENSOR | STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF | LGW | MEDTRONIC MED REL MEDTRONIC PUERTO RICO | 37714 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Required Intervention |