FDA Adverse Event
Injury
Summary report: N
INTERSTIM II
MDR report key: 3407772
·
Received October 14, 2013
Report
- Report Number
- 3004209178-2013-19024
- Event Type
- Injury
- Date Received
- October 14, 2013
- Report Date
- September 21, 2013
- Manufacturer
- MEDTRONIC MED REL MEDTRONIC PUERTO RICO
- Product Code
- EZW
- PMA / PMN Number
- P970004
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- AL, US
- Reporter Occupation
- PHYSICIAN
Narratives
Additional Manufacturer Narrative · 1
CONCOMITANT: PRODUCT ID 3037, SERIAL# (B)(4), PRODUCT TYPE PROGRAMMER, PATIENT; PRODUCT ID 3 093-28, LOT# V641092, IMPLANTED: (B)(6) 2011, PRODUCT TYPE LEAD. (B)(4).
Description of Event or Problem · 1
IT WAS REPORTED THE PATIENT EXPERIENCED A FLARE OF INTERSTITIAL CYSTITIS. INTERVENTIONS INCLUDED CYSTOSCOPY, HYDRODISTENTION, AND TRANSURETHRAL CAUTERIZATION OF "TIGONE" AS OUTPATIENT PROCEDURE ON (B)(6) 2013. THE PATIENT WAS MEDICATED WITH TYLOX AND PYRIDIUM. IT WAS STATED THIS WAS A WORSENING OR EXACERBATION OF A PRE-EXISTING CONDITION. SYMPTOMS INCLUDED SEVERE PAIN, FREQUENCY AND NOCTURIA.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 525617 | INTERSTIM II | STIMULATOR, ELECTRICAL, IMPLANTABLE, FOR INCONTINENCE | EZW | MEDTRONIC MED REL MEDTRONIC PUERTO RICO | 3058 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 00034 YR | Hospitalization| R |