FDA Adverse Event
Malfunction
Summary report: N
INTERSTIM
MDR report key: 1884863
·
Received October 15, 2010
Report
- Report Number
- 3004209178-2010-08014
- Event Type
- Malfunction
- Date Received
- October 15, 2010
- Date of Event
- January 1, 2010
- Report Date
- September 17, 2010
- Manufacturer
- MDT 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
A MFR'S REPRESENTATIVE REPORTED THAT THE PT EXPERIENCED A "SHOCKING OR JOLTING SENSATION WHEN GOING THROUGH SECURITY SYSTEMS." THE PT PASSED THROUGH "A THEFT DETECTOR OR SECURITY GATE AT (B)(6)" WHILE HER DEVICE WAS TURNED ON. THE PT WAS ADVISED TO TURN HER DEVICE OFF WHEN PASSING THROUGH SECURITY GATES AND THIS RESOLVED HER ISSUE. A FOLLOW-UP REPORT WILL BE SENT IF ADDITIONAL INFO BECOMES AVAILABLE.
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 | 44 YR | PROGRAMMER: MODEL 3037, LOT # NJD111415N| EXPLANTED:| EXTENSION: MODEL EXTENSION, LOT # UNK| IMPLANTED:| LEAD: MODEL 3889, LOT #V514032| EXPLANTED:| IMPLANTED:| EXPLANTED:| IMPLANTED: |