FDA Adverse Event
Injury
Summary report: N
INTERSTIM II
MDR report key: 3491852
·
Received November 27, 2013
Report
- Report Number
- 3004209178-2013-21595
- Event Type
- Injury
- Date Received
- November 27, 2013
- Report Date
- November 6, 2013
- Manufacturer
- MEDTRONIC MED REL MEDTRONIC PUERTO RICO
- Product Code
- EZW
- PMA / PMN Number
- P970004
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- OH, US
- Reporter Occupation
- PHYSICIAN
Narratives
Additional Manufacturer Narrative · 1
PRODUCT ID: 3889-33, LOT# V172550, IMPLANTED: (B)(6) 2009, PRODUCT TYPE: LEAD. PRODUCT ID: 3037, SERIAL# (B)(4), IMPLANTED: (B)(6) 2009, PRODUCT TYPE: PROGRAMMER. (B)(4).
Description of Event or Problem · 1
IT WAS REPORTED THE PATIENT HAD UNSPECIFIED VAGINITIS AND VULVOVAGINITIS. THE PATIENT WAS PRESCRIBED TERAZOL VAGINAL CREAM AT BEDTIME FOR THREE DAYS AND AMOXICILLIN. IT WAS STATED THIS WAS A NEW ILLNESS OR INJURY AND THERE WERE NO SYMPTOMS LISTED. IT WAS REPORTED THE PATIENT¿S ISSUE RESOLVED WITHOUT SEQUELAE ON (B)(6) 2009.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 618312 | INTERSTIM II | STIMULATOR, ELECTRICAL, IMPLANTABLE, FOR INCONTINENCE | EZW | MEDTRONIC MED REL MEDTRONIC PUERTO RICO | 3058 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 00032 YR | Required Intervention |