RESTORE ADVANCED
Report
- Report Number
- 3004209178-2013-05847
- Event Type
- Injury
- Date Received
- April 10, 2013
- Report Date
- May 22, 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
- PHYSICIAN
Narratives
(B)(4).
FINAL ANALYSIS OF THE STIMULATOR REVEALED NO SIGNIFICANT ANOMALIES. STIMULATION IS FUNCTIONALLY OKAY. FINAL ANALYSIS OF THE ACCESSORY KIT REVEALED NO ANOMALY FOUND. (B)(4).
PRODUCT ID: 3998 LOT# V023517, IMPLANTED: 2004 (B)(6), PRODUCT TYPE LEAD PRODUCT ID: 3708260 LOT# SERIAL# (B)(4), IMPLANTED: 2012 (B)(6), PRODUCT TYPE EXTENSION PRODUCT ID: 3998 LOT# VA00VYF, IMPLANTED: 2012 (B)(6), PRODUCT TYPE LEAD PRODUCT ID: 37743 LOT# SERIAL# (B)(4), PRODUCT TYPE PROGRAMMER, PATIENT PRODUCT ID:37752 LOT# SERIAL# (B)(4), PRODUCT TYPE RECHARGER. (B)(4).
IT WAS REPORTED, THERE WAS AN UNKNOWN IMPEDANCE ISSUE. IT WAS ALSO NOTED, THE PATIENT HAD A FALL. IT WAS NOTED THERE WAS A REPLACEMENT PLANNED FOR (B)(6) 2013. PATIENT STATUS AT THE TIME OF REPORT WAS NOTED AS ALIVE WITH NO INJURY OR ADVERSE EVENT. PATIENT SYMPTOMS INCLUDED LOSS OF THERAPY.
FOLLOW UP REPORTED THE STIMULATOR WAS REPLACED AND THE PATIENT WAS RECEIVING GOOD COVERAGE.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 153153 | RESTORE ADVANCED | STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF | LGW | MEDTRONIC MED REL MEDTRONIC PUERTO RICO | 37713 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Required Intervention |