FDA Adverse Event
Injury
Summary report: N
INTERSTIM II
MDR report key: 6771601
·
Received August 7, 2017
Report
- Report Number
- 3004209178-2017-16354
- Event Type
- Injury
- Date Received
- August 7, 2017
- Report Date
- August 7, 2017
- Manufacturer
- MEDTRONIC MED REL MEDTRONIC PUERTO RICO
- Product Code
- EZW
- PMA / PMN Number
- P970004
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- MI, US
- Reporter Occupation
- PHYSICIAN
Narratives
Additional Manufacturer Narrative · 1
INFORMATION REFERENCES THE MAIN COMPONENT OF THE SYSTEM AND OTHER APPLICABLE COMPONENTS ARE: PRODUCT ID 3889-28, LOT# V933654, IMPLANTED: (B)(6) 2012, PRODUCT TYPE LEAD.
Description of Event or Problem · 1
PATIENT HAD RETURN OF SYMPTOMS. PATIENT HAD IMPEDANCE CHECK AND PROGRAM CHANGES WERE DONE. EXPLANT SURGERY WAS PLANNED FOR WHOLE SYSTEM ON (B)(6) 2017. PATIENT WAS ADVISED TO CONSULT WITH DOCTOR FOR MORE INFORMATION. THERE WERE NO COMPLICATIONS OR THAT NO FURTHER COMPLICATIONS WERE REPORTED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 551555 | INTERSTIM II | STIMULATOR, ELECTRICAL, IMPLANTABLE, FOR INCONTINENCE | EZW | MEDTRONIC MED REL MEDTRONIC PUERTO RICO | 3058 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Required Intervention |