FDA Adverse Event
Injury
Summary report: N
UNKNOWN IMPLANTABLE STIMULATOR
MDR report key: 3864266
·
Received June 10, 2014
Report
- Report Number
- 3007566237-2014-01589
- Event Type
- Injury
- Date Received
- June 10, 2014
- Date of Event
- January 16, 2014
- Report Date
- May 19, 2014
- Manufacturer
- MEDTRONIC NEUROMODULATION
- Product Code
- LGW
- PMA / PMN Number
- P840001
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- FR
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
(B)(4).
Description of Event or Problem · 1
ADDITIONAL INFORMATION RECEIVED FROM THE HEALTHCARE PROFESSIONAL (HCP) OF A FOREIGN CLINICAL STUDY REPORTED THAT THE EVENT DATE WAS CHANGED TO (B)(6) 2014.
Description of Event or Problem · 1
IT WAS REPORTED THERE WAS AN INFECTION AT THE STIMULATOR POCKET. THE DEVICE WAS EXPLANTED AND ANTIBIOTIC TREATMENT WAS ADMINISTERED. THE EVENT WAS NOTED AS RESOLVED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 338594 | UNKNOWN IMPLANTABLE STIMULATOR | STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF | LGW | MEDTRONIC NEUROMODULATION | NEU_INS_STIMULATOR |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 00058 YR | Required Intervention |