FDA Adverse Event
Injury
Summary report: N
INTERSTIM II
MDR report key: 1961005
·
Received January 11, 2011
Report
- Report Number
- 3004209178-2011-00283
- Event Type
- Injury
- Date Received
- January 11, 2011
- Report Date
- January 6, 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
- NC, US
- Reporter Occupation
- NOT APPLICABLE
- Health Professional
- N
Narratives
Additional Manufacturer Narrative · 1
(B)(4).
Description of Event or Problem · 1
IT WAS REPORTED THAT THE PT WAS HOSPITALIZED DUE TO CONSTIPATION. THE PT ALSO NEVER HAD THERAPEUTIC EFFECT. THE PT HAS BEEN SEEN TWICE FOR REPROGRAMMING. REPROGRAMMING ALLEVIATED PAIN THAT THE PT EXPERIENCED AT INSERTION, BUT HAS NOT HELPED WITH SYMPTOM CONTROL. THE PT WAS FEELING STIMULATION NEAR THE RECTUM PREVIOUSLY, BUT WAS NO LONGER FEELING THIS. THAT PT WAS REDIRECTED TO HER PHYSICIAN.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | INTERSTIM II | EZW | MDT PUERTO RICO OPERATIONS CO., JUNCOS | 3058 | NA |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 81 YR | Female | Hospitalization | "SEE H10...."| "SEE H10...."| EXPLANTED:| IMPLANTED: | LEAD: MODEL 3093, LOT# V510428| PROGRAMMER: MODEL 3037, LOT# NJD110584N| EXPLANTED:| LEAD: MODEL 3093, LOT# V510428| PROGRAMMER: MODEL 3037, LOT# NJD110584N| IMPLANTED: |