FDA Adverse Event
Injury
Summary report: N
UNKNOWN NEUROSTIMULATOR
MDR report key: 2922417
·
Received January 18, 2013
Report
- Report Number
- 3007566237-2013-00229
- Event Type
- Injury
- Date Received
- January 18, 2013
- Report Date
- December 21, 2012
- Manufacturer
- MEDTRONIC NEUROMODULATION
- Product Code
- MRU
- PMA / PMN Number
- H020007
- Adverse Event
- Yes
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- NL
- Reporter Occupation
- PHYSICIAN
Narratives
Additional Manufacturer Narrative · 1
PRODUCT ID: 3389, LOT# UNKNOWN, PRODUCT TYPE: LEAD. (B)(4).
Additional Manufacturer Narrative · 1
(B)(4).
Additional Manufacturer Narrative · 1
(B)(4).
Description of Event or Problem · 1
ADDITIONAL REVIEW INDICATED THAT THE PATIENT HAD TO BE RE-OPERATED ON DUE TO LEAD MOVEMENT OR INFECTION. IT WAS UNCLEAR WHICH OF THESE TWO PERTAINED TO THE PATIENT.
Description of Event or Problem · 1
IT WAS REPORTED THAT A DOCTOR HAD RE-OPERATED ON 45 PATIENTS SINCE 1995, "SOME" DUE TO MOVEMENT OF THE LEAD. NO FURTHER INFORMATION WAS REPORTED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 27739 | UNKNOWN NEUROSTIMULATOR | IMPLANTED SUBCORTICAL ELECTRICAL STIMULATOR (MOTOR DISORDERS) | MRU | MEDTRONIC NEUROMODULATION | NEU_INS_STIMULATOR |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Required Intervention |