FDA Adverse Event
Injury
Summary report: N
INTERSTIM II
MDR report key: 4802021
·
Received May 28, 2015
Report
- Report Number
- 3004209178-2015-09812
- Event Type
- Injury
- Date Received
- May 28, 2015
- Report Date
- May 4, 2015
- Manufacturer
- MEDTRONIC MED REL MEDTRONIC PUERTO RICO
- Product Code
- EZW
- PMA / PMN Number
- P970004
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- MD, US
- Reporter Occupation
- PHYSICIAN
Narratives
Additional Manufacturer Narrative · 1
CONCOMITANT PRODUCTS: PRODUCT ID 3093-28, LOT # VA087SR, IMPLANTED: (B)(6) 2013, PRODUCT TYPE LEAD. (B)(4).
Description of Event or Problem · 1
IT WAS REPORTED THAT THE PATIENT HAD A DEVICE ON THE RIGHT SIDE, THERE WAS A BULGE, AND THE POCKET OPENED UP AT THE INCISION SITE. THE HEALTH CARE PROVIDER (HCP) THEN MOVED THE IMPLANTABLE NEUROSTIMULATOR (INS) TO THE LEFT SIDE ON (B)(6) 2014. THEY REMOVED THE INS ON THE RIGHT SIDE AND THE LEAD.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 347346 | INTERSTIM II | STIMULATOR, ELECTRICAL, IMPLANTABLE, FOR INCONTINENCE | EZW | MEDTRONIC MED REL MEDTRONIC PUERTO RICO | 3058 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Required Intervention |