FDA Adverse Event
Injury
Summary report: N
INTERSTIM II
MDR report key: 2230560
·
Received August 12, 2011
Report
- Report Number
- 3004209178-2011-06305
- Event Type
- Injury
- Date Received
- August 12, 2011
- Report Date
- July 18, 2011
- Manufacturer
- MDT PUERTO RICO OPERATIONS CO., JUNCOS
- Product Code
- EZW
- PMA / PMN Number
- P970004
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- MI, US
- Reporter Occupation
- NOT APPLICABLE
Narratives
Additional Manufacturer Narrative · 1
(B)(4).
Description of Event or Problem · 1
IT WAS REPORTED THAT THE PT FELT ITCHING AND BURNING IN HER VAGINA AND HER URINE TURNED "MILKY WHITE". THIS WAS THE FOURTH TIME SUCH SYMPTOMS HAD OCCURRED AND SHE HAD BEEN PRESCRIBED ANTIBIOTICS FOR THE CONDITION IN THE PAST. THE PT CONTACTED HER HEALTH CARE PROVIDER AND WAS AGAIN GOING TO BE GIVEN ANTIBIOTICS FOR THE CONDITION. ADDITIONAL INFO HAS BEEN REQUESTED BUT WAS NOT AVAILABLE AS OF THE DATE OF THIS REPORT.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | INTERSTIM II | EZW | MDT PUERTO RICO OPERATIONS CO., JUNCOS | 3058 | NA |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Required Intervention | PROGRAMMER: MODEL 3037, LOT # NJD115338N| IMPLANTED:| LEAD: MODEL 3889, LOT # V534733| EXPLANTED: |