FDA Adverse Event
Injury
Summary report: N
RESTORE ADVANCED
MDR report key: 3143486
·
Received June 3, 2013
Report
- Report Number
- 3004209178-2013-08580
- Event Type
- Injury
- Date Received
- June 3, 2013
- Report Date
- May 13, 2013
- Manufacturer
- MEDTRONIC MED REL MEDTRONIC PUERTO RICO
- Product Code
- LGW
- PMA / PMN Number
- P840001
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- MN, US
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
PRODUCT ID 39565-65, SERIAL# (B)(4), IMPLANTED: 2011-(B)(6), EXPLANTED: 2013-(B)(6), PRODUCT TYPE LEAD. (B)(4).
Description of Event or Problem · 1
IT WAS REPORTED THAT A PATIENT WENT IN FOR A LEAD REVISION DUE TO INADEQUATE COVERAGE ON THE LEFT SIDE AND A DIFFERENT KIND OF LEAD WAS GOING TO BE IMPLANTED. THE REPORTER STATED THAT DURING THE CASE THE PATIENT ¿HAD ISSUES WITH ANESTHESIA IN REGARDS TO BLOOD PRESSURE¿ AND THE CASE WAS ABORTED. IT WAS REPORTED THAT THE LEAD AND IMPLANTABLE NEUROSTIMULATOR WERE EXPLANTED AND NO DEVICES REMAINED IMPLANTED AT THE TIME.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 243678 | 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 | 00045 YR | Required Intervention |