FDA Adverse Event
Malfunction
Summary report: N
RESTORE
MDR report key: 9225075
·
Received October 23, 2019
Report
- Report Number
- 3004209178-2019-20229
- Event Type
- Malfunction
- Date Received
- October 23, 2019
- Date of Event
- January 1, 2012
- Report Date
- October 23, 2019
- 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
- NC, US
- Reporter Occupation
- 003
Narratives
Additional Manufacturer Narrative · 1
CONCOMITANT MEDICAL PRODUCTS: PRODUCT ID: 37714, SERIAL#: (B)(4), IMPLANTED: (B)(6) 2012, PRODUCT TYPE: IMPLANTABLE NEUROSTIMULATOR. PRODUCT ID: 399945, LOT#: V013893, IMPLANTED: (B)(6) 2007, EXPLANTED: (B)(6) 2012, PRODUCT TYPE: LEAD. OTHER RELEVANT DEVICE(S) ARE: PRODUCT ID: 399945, SERIAL/LOT #: (B)(4), UBD: 20-OCT-2010, UDI#: (B)(4). IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.
Description of Event or Problem · 1
INFORMATION WAS RECEIVED FROM A MANUFACTURER REP REGARDING A PATIENT WITH AN IMPLANTABLE NEUROSTIMULATOR (INS) FOR LUMBAR RADICULOPATHY AND SPINAL PAIN. THE PATIENT REPORTED THAT THEY HAD A LEAD REVISION IN THE PAST BECAUSE THE LEADS HAD BECOME LOOSE, NOT SECURED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1017753 | RESTORE | STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF | LGW | MEDTRONIC MED REL MEDTRONIC PUERTO RICO | 37711 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 52 YR | Required Intervention |