FDA Adverse Event
Injury
Summary report: N
INTERSTIM II
MDR report key: 5805909
·
Received July 19, 2016
Report
- Report Number
- 3004209178-2016-14489
- Event Type
- Injury
- Date Received
- July 19, 2016
- Report Date
- July 19, 2016
- Manufacturer
- MEDTRONIC MED REL MEDTRONIC PUERTO RICO
- Product Code
- EZW
- PMA / PMN Number
- P970004
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- GA, US
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
THE MAIN COMPONENT OF THE SYSTEM AND OTHER APPLICABLE COMPONENTS ARE: PRODUCT ID: 3889-28, LOT# V012404, IMPLANTED: (B)(6) 2006, EXPLANTED: (B)(6) 2016-, PRODUCT TYPE: LEAD.
Additional Manufacturer Narrative · 1
IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.
Description of Event or Problem · 1
THE MANUFACTURER REPRESENTATIVE REPORTED THAT THE PATIENT EXPERIENCED A DECREASE IN SYMPTOM RELIEF. IT WAS INDICATED THAT IMPEDANCES WERE CHECKED, AND THE IMPLANTABLE NEUROSTIMULATOR AND LEADS WERE REVISED. IT WAS UNKNOWN IF THE ISSUE WAS RESOLVED. THE PATIENT WAS IMPLANTED FOR URINARY DYSFUNCTION/SACRAL NERVE STIMULATION AND GASTROINTESTINAL/PELVIC FLOOR.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 457503 | INTERSTIM II | STIMULATOR, ELECTRICAL, IMPLANTABLE, FOR INCONTINENCE | EZW | MEDTRONIC MED REL MEDTRONIC PUERTO RICO | 3058 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Required Intervention |