FDA Adverse Event
Injury
Summary report: N
INTERSTIM II
MDR report key: 2624307
·
Received June 21, 2012
Report
- Report Number
- 3004209178-2012-04707
- Event Type
- Injury
- Date Received
- June 21, 2012
- Report Date
- May 24, 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
- AZ, US
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
PRODUCT ID 3889-28, LOT# V802377, IMPLANTED: 2011-(B)(6), PRODUCT TYPE LEAD, PRODUCT ID 3037, SERIAL# (B)(4), PRODUCT TYPE PROGRAMMER, (B)(4).
Description of Event or Problem · 1
IT WAS REPORTED THAT THE PATIENT EXPERIENCED A LOSS OF THERAPEUTIC EFFECT AND A HAD A BLADDER INFECTION SINCE "LAST (B)(6)." THE SYMPTOMS OCCURRED FOLLOWING A FALL IN (B)(6) 2011. AN APPOINTMENT WITH THE PATIENT'S UROLOGIST WAS SCHEDULED FOR (B)(6) 2012. ADDITIONAL INFORMATION RECEIVED REPORTED THAT THE PATIENT DID NOT HAVE CONCERNS WITH THE DEVICE OR THERAPY. THE PATIENT RECEIVED ASSISTANCE FROM HER PHYSICIAN.
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 |