FDA Adverse Event
Injury
Summary report: N
UNKNOWN IMPLANTABLE NEUROSTIMULATOR
MDR report key: 3944724
·
Received July 18, 2014
Report
- Report Number
- 3007566237-2014-02011
- Event Type
- Injury
- Date Received
- July 18, 2014
- Report Date
- June 26, 2014
- Manufacturer
- MEDTRONIC NEUROMODULATION
- Product Code
- LGW
- PMA / PMN Number
- P840001
- Adverse Event
- Yes
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
CORRECTION: THIS FIELD SHOULD HAVE BEEN REPORTED AS BOTH ADVERSE EVENT AND PRODUCT PROBLEM ON THE INITIAL REPORT.
Additional Manufacturer Narrative · 1
CONCOMITANT MEDICAL PRODUCTS: PRODUCT ID: NEU_UNKNOWN_LEAD, SERIAL# UNKNOWN, PRODUCT TYPE: LEAD. (B)(4).
Description of Event or Problem · 1
IT WAS REPORTED THAT MEDTRONIC DEVICES HAVE SIGNIFICANT PROBLEMS LIKE BATTERY LEAKAGE INSIDE OF PATIENTS, DEVICE TWISTING AROUND INSIDE PATIENTS, AND BROKEN LEADS. IT WAS ALSO NOTED THAT IT WAS SUSPECTED THAT IF THE SPINAL CORD STIMULATOR (SCS) COMPANIES INVESTIGATED INFECTED PATIENTS THEY WOULD FIND AN OBVIOUS FLAW IN THE STERILIZATION OF THE SCS IN THE FACTORY OR DURING IMPLANT.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 422727 | UNKNOWN IMPLANTABLE NEUROSTIMULATOR | STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF | LGW | MEDTRONIC NEUROMODULATION | NEU_INS_STIMULATOR |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Required Intervention |