FDA Adverse Event
Injury
Summary report: N
INTERSTIM II
MDR report key: 3150432
·
Received June 6, 2013
Report
- Report Number
- 3004209178-2013-08731
- Event Type
- Injury
- Date Received
- June 6, 2013
- Date of Event
- September 13, 2012
- Report Date
- January 24, 2013
- Manufacturer
- MEDTRONIC MED REL MEDTRONIC PUERTO RICO
- Product Code
- EZW
- PMA / PMN Number
- P970004
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- MI, US
- Reporter Occupation
- PHYSICIAN
Narratives
Additional Manufacturer Narrative · 1
CONCOMITANT MEDICAL PRODUCTS: PRODUCT ID 3037, SERIAL# (B)(4). PRODUCT TYPE: PROGRAMMER, PATIENT: PRODUCT ID 3889-28, LOT# V571447, IMPLANTED: (B)(6) 2010. PRODUCT TYPE: LEAD. (B)(4).
Description of Event or Problem · 1
IT WAS REPORTED THAT THE PATIENT HAD A URINARY TRACT INFECTION (UTI). THE PATIENT HAD A URINE CULTURE THAT WAS POSITIVE FOR E COLI. THE PATIENT WAS PRESCRIBED MACROBID 100 MG BID PO AND THEN CHANGED TO CIPRO PO BID. THE PATIENT OUTCOME WAS NOTED AS RESOLVED WITHOUT SEQUELAE.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 250181 | INTERSTIM II | STIMULATOR, ELECTRICAL, IMPLANTABLE, FOR INCONTINENCE | EZW | MEDTRONIC MED REL MEDTRONIC PUERTO RICO | 3058 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 00076 YR |