FDA Adverse Event
Injury
Summary report: N
ACTIVA RC
MDR report key: 2140975
·
Received June 21, 2011
Report
- Report Number
- 9614453-2011-04625
- Event Type
- Injury
- Date Received
- June 21, 2011
- Date of Event
- January 1, 2011
- Report Date
- May 24, 2011
- Manufacturer
- MEDTRONIC EUROPE SARL
- Product Code
- MHY
- PMA / PMN Number
- P960009
- Adverse Event
- Yes
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- IT
- Reporter Occupation
- PHYSICIAN
Narratives
Additional Manufacturer Narrative · 1
(B)(4).
Description of Event or Problem · 1
THE PATIENT'S LEFT SIDE LEAD AND EXTENSION WERE EXPLANTED DUE TO INFECTION. IT WAS LATER REPORTED THAT THE IMPLANTABLE NEUROSTIMULATOR (INS) REQUIRED FREQUENT RECHARGING AND WAS TURNING OFF BY ITSELF. THERE WAS NO CORRELATION BETWEEN THE INS TURNING OFF AND EXTERNAL INTERFERENCE. THE INS WAS INTERROGATED AND THE IMPEDANCES ON THE RIGHT SIDE WERE <250 OHMS. THE PATIENT WAS NOT INJURED DUE TO THE LOW IMPEDANCES. A FOLLOW-UP REPORT WILL BE SENT IF ADDITIONAL INFORMATION BECOMES AVAILABLE.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | ACTIVA RC | MHY | MEDTRONIC EUROPE SARL | 37612 | NA |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Other| R | EXPLANTED:| LEAD: MODEL 3389, LOT# UNKNOWN| IMPLANTED: |