RESTORE SENSOR
Report
- Report Number
- 3004209178-2013-04749
- Event Type
- Injury
- Date Received
- April 5, 2013
- Report Date
- March 21, 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
- CA, US
- Reporter Occupation
- OTHER
Narratives
(B)(4).
CONCOMITANT MEDICAL PRODUCTS: PRODUCT ID 3487A-56, LOT# VA005N5, IMPLANTED: (B)(6) 2012. PRODUCT TYPE: LEAD: PRODUCT ID 3487A-56, LOT# VA005N5, IMPLANTED: (B)(6) 2012. PRODUCT TYPE: LEAD: PRODUCT ID 3487A-56, LOT# VA005N5, IMPLANTED: (B)(6) 2012. PRODUCT TYPE: LEAD: PRODUCT ID 3487A-56, LOT# V931748, IMPLANTED: (B)(6) 2012. PRODUCT TYPE: LEAD: PRODUCT ID 37744, SERIAL# (B)(4). PRODUCT TYPE: PROGRAMMER, PATIENT: PRODUCT ID 37754, SERIAL# (B)(4). PRODUCT TYPE: RECHARGER: PRODUCT ID 3708220, SERIAL# (B)(4), IMPLANTED: (B)(6) 2012. PRODUCT TYPE: EXTENSION: PRODUCT ID 3708220, SERIAL# (B)(4), IMPLANTED: (B)(6) 2012. PRODUCT TYPE: EXTENSION. (B)(4).
(B)(4).
IT WAS REPORTED THAT THE IMPLANTABLE NEUROSTIMULATOR (INS) WAS MOVING ALL OVER THE PLACE BECAUSE THE PLACEMENT WAS BAD.
IT WAS REPORTED THE PATIENT HAD 2 LEADS AND THE IMPLANTABLE NEUROSTIMULATOR (INS) REPLACED ON (B)(6) 2013. THE INS HAD BEEN IMPLANTED IN THE ARM PIT, AND WAS MOVING "ALL OVER THE PLACE." THE INS WAS MOVED TO THE COLLAR BONE AREA TO PREVENT MOVEMENT. IT WAS ALSO REPORTED THE LEADS WERE NOT WORKING. IT WAS REPORTED THE ISSUES STARTED TO OCCUR AT THE END OF (B)(6).
ADDITIONAL INFORMATION RECEIVED REPORTED THAT THE PATIENT'S IMPLANTABLE NEUROSTIMULATOR (INS) HAD A LOT OF ISSUES.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 140338 | 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 |