FDA Adverse Event
Injury
Summary report: N
ITREL
MDR report key: 2052646
·
Received April 7, 2011
Report
- Report Number
- 3007566237-2011-02661
- Event Type
- Injury
- Date Received
- April 7, 2011
- Date of Event
- February 21, 2010
- Report Date
- March 17, 2011
- Manufacturer
- MEDTRONIC NEUROMODULATION
- Product Code
- EZW
- PMA / PMN Number
- P970004
- Adverse Event
- Yes
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- MI, US
- Reporter Occupation
- PHYSICIAN
- Health Professional
- Yes
Narratives
Additional Manufacturer Narrative · 1
(B)(4).
Description of Event or Problem · 1
IT WAS REPORTED THAT A TRIAL EXPERIENCED DECREASED RESPONSE FROM THE TEST STIMULATION FOLLOWING A FALL WHERE THEY "POSSIBLY" PULLED ON HER EXTERNAL CABLE. SEVERAL REPROGRAMMING CHANGES WERE MADE ON (B)(6) 2011 WITHOUT POSITIVE RESULTS. A LEAD REVISION WAS THEN PERFORMED ON (B)(6) 2011 WHERE THE LEAD WAS PLACED ON THE PATIENT'S LEFT SIDE. THE PATIENT RECOVERED WITHOUT SEQUELAE.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | ITREL | EZW | MEDTRONIC NEUROMODULATION | 3625 | NA |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 49 YR | Female | Required Intervention | EXPLANTED:| IMPLANTED:| LEAD: MODEL 3889, LOT# V621113| LEAD: MODEL 3889, LOT# V621113| EXPLANTED:| IMPLANTED: |