FDA Adverse Event
Injury
Summary report: N
SURESCAN
MDR report key: 3973757
·
Received August 1, 2014
Report
- Report Number
- 3004209178-2014-13847
- Event Type
- Injury
- Date Received
- August 1, 2014
- Report Date
- July 10, 2014
- Manufacturer
- MEDTRONIC PUERTO RICO OPERATIONS CO.
- 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
CONCOMITANT PRODUCTS: PRODUCT ID 977A260, SERIAL# (B)(4), IMPLANTED: (B)(6) 2014, PRODUCT TYPE LEAD; PRODUCT ID 977A260, SERIAL# (B)(4), IMPLANTED: (B)(6) 2014, PRODUCT TYPE LEAD; PRODUCT ID 97754, SERIAL# (B)(4), PRODUCT TYPE RECHARGER; PRODUCT ID 97740, SERIAL# (B)(4), PRODUCT TYPE PROGRAMMER, PATIENT. (B)(4).
Description of Event or Problem · 1
IT WAS REPORTED THE PATIENT HAD AN INFECTION AND THE NEUROSTIMULATION SYSTEM WAS REMOVED. THE REPORTER STATED IT WAS UNKNOWN IF THE ENTIRE DEVICE OR PARTIAL DEVICE WAS REMOVED. ADDITIONAL INFORMATION WAS REQUESTED, BUT WAS NOT AVAILABLE AS OF THE DATE OF THIS REPORT.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 451290 | SURESCAN | STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF | LGW | MEDTRONIC PUERTO RICO OPERATIONS CO. | 97714 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Required Intervention |