FDA Adverse Event
Injury
Summary report: N
INTERSTIM II
MDR report key: 2052524
·
Received April 11, 2011
Report
- Report Number
- 3007566237-2011-02726
- Event Type
- Injury
- Date Received
- April 11, 2011
- Date of Event
- March 1, 2011
- Report Date
- April 4, 2011
- Manufacturer
- MEDTRONIC NEUROMODULATION
- Product Code
- EZW
- PMA / PMN Number
- P970004
- Adverse Event
- Yes
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- MO, US
- Reporter Occupation
- PHYSICIAN
Narratives
Additional Manufacturer Narrative · 1
(B)(4).
Description of Event or Problem · 1
IT WAS INITIALLY REPORTED THAT THE STIMULATION WAS NOT CONTROLLING THE PT'S URINARY ISSUES. IT WAS FURTHER REPORTED BY THE PT'S PHYSICIAN THAT IMPEDANCES WERE GREATER THAN 4000 OHMS IN 2 OF THE ELECTRODES. THE PHYSICIAN CONFIRMED THE LACK OF THERAPEUTIC EFFECT AS WELL AS THE LACK OF STIMULATION. THE EVENT WAS ATTRIBUTED TO THE LEAD. THE LEAD WAS REPLACED. THERE WERE NO INJURIES.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | INTERSTIM II | EZW | MEDTRONIC NEUROMODULATION | IPG URO | NA |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Required Intervention | EXPLANTED:| LEAD: MODEL LEAD URO, LOT# UNK| IMPLANTED:| PROGRAMMER: MODEL PROGRAMMER, LOT# UNK |