FDA Adverse Event
Injury
Summary report: N
INTERSTIM II
MDR report key: 4806360
·
Received May 29, 2015
Report
- Report Number
- 3004209178-2015-09979
- Event Type
- Injury
- Date Received
- May 29, 2015
- Report Date
- May 6, 2015
- 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
- MD, US
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
CONCOMITANT MEDICAL PRODUCTS: PRODUCT ID: 3093-33, LOT# V911221, IMPLANTED: 2012-(B)(6), EXPLANTED: 2012-(B)(6), PRODUCT TYPE: LEAD. (B)(4).
Description of Event or Problem · 1
THE PATIENT REPORTED THAT AFTER BEING RELEASED FROM THE HOSPITAL. SHE WAS GETTING OUT OF THE CAR AND TWISTED THE WRONG WAY. THE STITCHES CAME OUT AND THE IMPLANTABLE NEUROSTIMULATOR (INS) CAME OUT OF THE POCKET. A REVISION OCCURRED AND THEY HAD TO MOVE THE INS FROM THE RIGHT TO THE LEFT SIDE. NO OUTCOME WAS REPORTED REGARDING THIS EVENT. A FURTHER FOLLOW-UP IS BEING CONDUCTED TO OBTAIN THIS INFORMATION. A FOLLOW-UP REPORT WILL BE SENT IF ADDITIONAL INFORMATION BECOMES AVAILABLE.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 349372 | INTERSTIM II | STIMULATOR, ELECTRICAL, IMPLANTABLE, FOR INCONTINENCE | EZW | MEDTRONIC MED REL MEDTRONIC PUERTO RICO | 3058 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 00040 YR | Required Intervention |