FDA Adverse Event
Malfunction
Summary report: N
INTERSTIM II
MDR report key: 3181921
·
Received June 21, 2013
Report
- Report Number
- 3004209178-2013-10701
- Event Type
- Malfunction
- Date Received
- June 21, 2013
- Report Date
- May 31, 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
- WV, US
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
CONCOMITANT PRODUCTS: PRODUCT ID: 3037, SERIAL# (B)(4), PRODUCT TYPE: PROGRAMMER. PATIENT PRODUCT ID: 3095-10, SERIAL# (B)(4), IMPLANTED: (B)(6) 2009, PRODUCT TYPE: EXTENSION. PRODUCT ID: 3093-28, LOT# V235031, IMPLANTED: (B)(6) 2009. PRODUCT TYPE: LEAD. (B)(4).
Description of Event or Problem · 1
IT WAS REPORTED THAT THE PATIENT WAS BEING ZAPPED ON THE RIGHT LEG AND BOTTOM OF HER CHEEK THE LAST3-4 DAYS. THERE WAS NO KNOWN PATIENT ACCIDENT OR INCIDENT RELATED TO THIS EVENT. IT WAS NOTED THAT THE PATIENT¿S DEVICE HAD BEEN REPLACED TWICE. FOLLOW-UP INFORMATION RECEIVED REPORTED THAT THE PATIENT WAS STILL HAVING CONCERNS REGARDING HER THERAPY/DEVICE, BUT HAD NOT SOUGHT FURTHER HELP. IT WAS NOTED THAT THE PATIENT WAS WAITING TO HEAR BACK FROM THE MANUFACTURER REPRESENTATIVE.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 282088 | INTERSTIM II | STIMULATOR, ELECTRICAL, IMPLANTABLE, FOR INCONTINENCE | EZW | MEDTRONIC MED REL MEDTRONIC PUERTO RICO | 3058 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 00051 YR |