FDA Adverse Event
Injury
Summary report: N
INTERSTIM II
MDR report key: 3103271
·
Received May 9, 2013
Report
- Report Number
- 3004209178-2013-07477
- Event Type
- Injury
- Date Received
- May 9, 2013
- Report Date
- April 17, 2013
- Manufacturer
- MEDTRONIC MED REL MEDTRONIC PUERTO RICO
- Product Code
- EZW
- PMA / PMN Number
- P080025
- Adverse Event
- Yes
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- ND, US
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
CONCOMITANT MEDICAL PRODUCTS: PRODUCT ID 3037, SERIAL# (B)(4). PRODUCT TYPE: PROGRAMMER, PATIENT: PRODUCT ID 3 889-28, LOT# V516929, IMPLANTED: (B)(6) 2010. PRODUCT TYPE: LEAD. (B)(4).
Additional Manufacturer Narrative · 1
(B)(4).
Description of Event or Problem · 1
IT WAS REPORTED THAT TWO OF THE LEAD WIRES WERE BROKEN. IT WAS NOTED THAT THE PATIENT WAS SCHEDULED FOR A REPLACEMENT SURGERY, TO BE DONE ON (B)(6) 2013. IT WAS NOTED THAT DURING THE PATIENT'S PREOPERATIVE APPOINTMENT THE PATIENT'S BLOOD PRESSURE WAS TOO HIGH, SO BLOOD PRESSURE MEDICATION WAS GIVEN TO THE PATIENT. IT WAS FURTHER NOTED THAT THE HEALTH CARE PROFESSIONAL (HCP) STATED THEY COULD NOT DO THE SURGERY IF THE PATIENT'S BLOOD PRESSURE WAS TOO HIGH. PATIENT WAS CHECKING BLOOD PRESSURE ON THEIR OWN AND IT WAS STILL TOO HIGH.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 203464 | INTERSTIM II | STIMULATOR, ELECTRICAL, IMPLANTABLE, FOR INCONTINENCE | EZW | MEDTRONIC MED REL MEDTRONIC PUERTO RICO | 3058 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Required Intervention |