FDA Adverse Event
Injury
Summary report: N
INTERSTIM II
MDR report key: 2842530
·
Received November 21, 2012
Report
- Report Number
- 3004209178-2012-10643
- Event Type
- Injury
- Date Received
- November 21, 2012
- Report Date
- October 26, 2012
- Manufacturer
- MEDTRONIC MED REL MEDTRONIC PUERTO RICO
- Product Code
- EZW
- PMA / PMN Number
- P970004
- Adverse Event
- Yes
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- WI, US
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
PRODUCT ID 3889-28, LOT# V152799, IMPLANTED: (B)(6) 2008, EXPLANTED: (B)(6) 2012, PRODUCT TYPE LEAD. (B)(4).
Description of Event or Problem · 1
IT WAS REPORTED THERE WAS A REVISION SURGERY AND THE PATIENT RECEIVED A COMPLETE NEW SYSTEM. ADDITIONAL INFORMATION HAS BEEN REQUESTED, BUT WAS NOT AVAILABLE AS OF THE DATE OF THIS REPORT.
Description of Event or Problem · 1
FOLLOW UP REPORTED THE PATIENT DID NOT HAVE CONCERNS WITH THEIR DEVICE OR THERAPY. THE PATIENT HAD RECEIVED ASSISTANCE FROM THEIR DOCTOR OR REPRESENTATIVE AND THEIR CONCERNS HAD RESOLVED. IT WAS NOTED THERE WERE APPOINTMENTS ON (B)(6) 2012 AND (B)(6) 2013.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | INTERSTIM II | STIMULATOR, ELECTRICAL, IMPLANTABLE, FOR INCONTINENCE | EZW | MEDTRONIC MED REL MEDTRONIC PUERTO RICO | 3058 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Required Intervention |