FDA Adverse Event
Malfunction
Summary report: N
INTERSTIM II
MDR report key: 3143268
·
Received June 3, 2013
Report
- Report Number
- 3004209178-2013-08566
- Event Type
- Malfunction
- Date Received
- June 3, 2013
- Date of Event
- May 11, 2013
- Report Date
- May 13, 2013
- 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
- NY, US
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
(B)(4).
Additional Manufacturer Narrative · 1
CONCOMITANT PRODUCTS: PRODUCT ID 3037, SERIAL# (B)(4), PRODUCT TYPE PROGRAMMER, PATIENT; PRODUCT ID 3889-28, LOT# VA0422Y, IMPLANTED: (B)(6) 2013, PRODUCT TYPE LEAD. (B)(4).
Description of Event or Problem · 1
IT WAS REPORTED THAT THE PATIENT FELL ¿RIGHT ON THE DEVICE¿ ON (B)(6) 2013. THE PATIENT¿S ¿PEEING CAME RIGHT BACK¿ AND SHE WANTED TO KNOW WHAT TO DO. ADDITIONAL INFORMATION WAS REQUESTED, BUT WAS NOT AVAILABLE AS OF THE DATE OF THIS REPORT.
Description of Event or Problem · 1
AFTER FURTHER REVIEW, IT WAS NOTED THAT THE DEVICE WAS WORKING BUT ¿IT¿S VERY SLIGHT¿ AND COULD ¿BARELY¿ FEEL NOW. THE PATIENT NOTED THAT SYMPTOMS WERE GETTING WORSE AND THE PATIENT WAS IRRITATED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 244976 | INTERSTIM II | STIMULATOR, ELECTRICAL, IMPLANTABLE, FOR INCONTINENCE | EZW | MEDTRONIC MED REL MEDTRONIC PUERTO RICO | 3058 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 00026 YR |