FDA Adverse Event
Malfunction
Summary report: N
INTERSTIM II
MDR report key: 3149830
·
Received June 6, 2013
Report
- Report Number
- 3004209178-2013-08715
- Event Type
- Malfunction
- Date Received
- June 6, 2013
- Date of Event
- January 23, 2013
- Report Date
- May 16, 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
- MI, US
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
CONCOMITANT PRODUCTS: PRODUCT ID 3889-28, LOT # V861091, IMPLANTED: (B)(6) 2011, PRODUCT TYPE LEAD; PRODUCT ID 3037, SERIAL # (B)(4), PRODUCT TYPE PROGRAMMER, PATIENT. (B)(4).
Description of Event or Problem · 1
IT WAS REPORTED THAT SINCE (B)(6) 2013 THE PATIENT¿S DEVICE DID NOT SEEM TO BE HELPING WITH THEIR SYMPTOMS. THE PATIENT¿S HCP WAS NOTIFIED OF THE ISSUES AND STATED THAT A MANUFACTURER REPRESENTATIVE NEEDED TO ¿RE-SET¿ THE DEVICE. ADDITIONAL INFORMATION HAS BEEN REQUESTED, BUT WAS NOT AVAILABLE AS OF THE DATE OF THIS REPORT.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 251478 | INTERSTIM II | STIMULATOR, ELECTRICAL, IMPLANTABLE, FOR INCONTINENCE | EZW | MEDTRONIC MED REL MEDTRONIC PUERTO RICO | 3058 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 00054 YR |