FDA Adverse Event
Injury
Summary report: N
INTERSTIM II
MDR report key: 3955395
·
Received July 24, 2014
Report
- Report Number
- 3004209178-2014-13483
- Event Type
- Injury
- Date Received
- July 24, 2014
- Report Date
- July 5, 2014
- Manufacturer
- MEDTRONIC MED REL MEDTRONIC PUERTO RICO
- Product Code
- EZW
- PMA / PMN Number
- P970004
- Adverse Event
- Yes
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- VA, US
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
PRODUCT ID 3093-28, LOT# VA08T0N, IMPLANTED: 2013 (B)(6); PRODUCT TYPE LEAD PRODUCT ID 3037, SERIAL# (B)(4); PRODUCT TYPE PROGRAMMER, PATIENT. (B)(4).
Description of Event or Problem · 1
IT WAS REPORTED THAT THE PATIENT¿S WIRE CAME LOOSE 2 MONTHS AGO AND THAT WAS WHEN THEY LOST CONTROL OF THEIR BLADDER. IT WAS NOTED THAT THEY DIDN¿T KNOW IF THE SYMPTOM RETURN WAS GRADUAL OR SUDDEN. THE IMPLANT WAS REPLACED 4 DAYS AGO AND THEY DIDN¿T KNOW HOW IT GOT DISCONNECTED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 433623 | INTERSTIM II | STIMULATOR, ELECTRICAL, IMPLANTABLE, FOR INCONTINENCE | EZW | MEDTRONIC MED REL MEDTRONIC PUERTO RICO | 3058 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Required Intervention |