FDA Adverse Event
Injury
Summary report: N
INTERSTIM
MDR report key: 2220244
·
Received August 16, 2011
Report
- Report Number
- 3004209178-2011-06411
- Event Type
- Injury
- Date Received
- August 16, 2011
- Report Date
- July 22, 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
- IL, US
- Reporter Occupation
- NOT APPLICABLE
Narratives
Additional Manufacturer Narrative · 1
(B)(4).
Description of Event or Problem · 1
IT WAS REPORTED THAT THE PT FELT NO STIMULATION SENSATION WHEN SHE INCREASED HER SETTINGS. THE PT RECENTLY WENT THROUGH SECURITY AT A RETAIL STORE. THE PT HAD A URINARY TRACT INFECTION ABOUT THREE WEEKS AGO AND WAS TREATED FOR IT. THE PT EXPERIENCED PAIN IN HER PELVIC AREA. DURING TROUBLESHOOTING WHILE INCREASING STIMULATION, THE PT FELT THAT HER SHOULDERS WERE TIGHTENING. ADD'L INFO 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 |
|---|---|---|---|---|---|---|---|
| 1 | INTERSTIM | EZW | MDT PUERTO RICO OPERATIONS CO., JUNCOS | 3023 | NA |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Required Intervention | LEAD: MODEL 3093, LOT# V042808| EXTENSION: MODEL 3095, LOT# NAH035926V| IMPLANTED:| EXPLANTED:| EXPLANTED:| IMPLANTED:| PROGRAMMER: MODEL 3037, LOT# NJD050860N |