FDA Adverse Event
Malfunction
Summary report: N
INTERSTIM
MDR report key: 2053624
·
Received March 1, 2011
Report
- Report Number
- 3004209178-2011-01532
- Event Type
- Malfunction
- Date Received
- March 1, 2011
- Report Date
- February 21, 2011
- Manufacturer
- MDT PUERTO RICO OPERATIONS CO., JUNCOS
- Product Code
- EZW
- PMA / PMN Number
- P970004
- Adverse Event
- Yes
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- CT, US
- Reporter Occupation
- NOT APPLICABLE
Narratives
Additional Manufacturer Narrative · 1
(B)(4).
Description of Event or Problem · 1
IT WAS REPORTED THAT AFTER GOING THROUGH AIRPORT SECURITY, THE PT FELT NO STIMULATION. THE PT FORGOT HER PROGRAMMER. THE DEVICE WAS TURNED OFF AT THE TIME OF THE EXPOSURE. THE PT HAD PAIN, BUT IT WAS UNCLEAR IF IT WAS PRE-EXISTING OR RELATED TO THE DEVICE. ADDITIONAL INFO WAS REQUESTED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | INTERSTIM | EZW | MDT PUERTO RICO OPERATIONS CO., JUNCOS | 3023 | NA |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | IMPLANTED:| LEAD: MODEL 3080, LOT# L53645| EXPLANTED:| EXTENSION: MODEL 3095, LOT# NAH046978V| PROGRAMMER: MODEL 3037, LOT# NJD116960N| EXPLANTED:| IMPLANTED: |