FDA Adverse Event
Malfunction
Summary report: N
INTERSTIM II
MDR report key: 2101688
·
Received May 10, 2011
Report
- Report Number
- 3004209178-2011-03375
- Event Type
- Malfunction
- Date Received
- May 10, 2011
- Date of Event
- April 11, 2011
- Report Date
- April 11, 2011
- Manufacturer
- MEDTRONIC PUERTO RICO OPERATIONS CO., JUNCOS
- Product Code
- EZW
- PMA / PMN Number
- P970004
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- MN, US
- Reporter Occupation
- NOT APPLICABLE
Narratives
Additional Manufacturer Narrative · 1
(B)(4).
Description of Event or Problem · 1
IT WAS REPORTED THAT PRIOR TO IMPLANT, THE MANUFACTURER'S REPRESENTATIVE WAS UNABLE TO COMMUNICATE WITH THE DEVICE. TROUBLESHOOTING WAS TRIED WITHOUT SUCCESS.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | INTERSTIM II | EZW | MEDTRONIC PUERTO RICO OPERATIONS CO., JUNCOS | 3058 | NA |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |