FDA Adverse Event
Injury
Summary report: N
UNKNOWN IMPLANTABLE NEUROSTIMULATOR
MDR report key: 3012415
·
Received March 20, 2013
Report
- Report Number
- 3007566237-2013-00835
- Event Type
- Injury
- Date Received
- March 20, 2013
- Date of Event
- September 4, 2012
- Report Date
- March 7, 2013
- 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
CONCOMITANT MEDICAL PRODUCT: PRODUCT ID: 37081-40, SERIAL#: UNKNOWN, IMPLANTED: (B)(6) 2012, PRODUCT TYPE: EXTENSION. (B)(4).
Additional Manufacturer Narrative · 1
(B)(4).
Additional Manufacturer Narrative · 1
(B)(4).
Description of Event or Problem · 1
IT WAS REPORTED THE PATIENT HAD AN INFECTION. NURSE CARE RESOLVED THE INCIDENT AND THE PATIENT WAS WELL AT THE TIME OF REPORT.
Description of Event or Problem · 1
ADDITIONAL INFORMATION RECEIVED FROM THE HEALTHCARE PROFESSIONAL (HCP) OF A FOREIGN CLINICAL STUDY REPORTED THAT THE PATIENT HAD AN INFECTION AT THE LEAD IMPLANTATION SITE.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 115770 | UNKNOWN IMPLANTABLE NEUROSTIMULATOR | STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF | LGW | MEDTRONIC NEUROMODULATION | NEU_INS_STIMULATOR |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 00080 YR | Required Intervention |