FDA Adverse Event
Injury
Summary report: N
INTERSTIM
MDR report key: 4908580
·
Received July 13, 2015
Report
- Report Number
- 3007566237-2015-01938
- Event Type
- Injury
- Date Received
- July 13, 2015
- Report Date
- June 22, 2015
- Manufacturer
- MEDTRONIC NEUROMODULATION
- Product Code
- EZW
- PMA / PMN Number
- P970004
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- FL, US
- Reporter Occupation
- PATIENT
Narratives
Additional Manufacturer Narrative · 1
(B)(4).
Additional Manufacturer Narrative · 1
PRODUCT ID NEU_UNKNOWN_LEAD, LOT# UNKNOWN; PRODUCT TYPE LEAD. (B)(4).
Description of Event or Problem · 1
IT WAS REPORTED THAT THE PATIENT HAD EXCELLENT RESULTS FROM THEIR TRIAL PHASE OF TESTING FOR THE NEUROSTIMULATOR ¿WENT GREAT¿ AND WAS ¿EXCELLENT¿ EXCEPT THEY HAD A URINARY TRACT INFECTION. THEY HAD NOT BEEN IMPLANTED WITH THE DEVICE AT THE TIME OF REPORT. THERE WERE NO FURTHER DETAILS, INTERVENTIONS OR AN OUTCOME WAS REPORTED REGARDING THIS EVENT. FURTHER FOLLOW-UP IS BEING CONDUCTED TO OBTAIN THIS INFORMATION. IF ADDITIONAL INFORMATION IS RECEIVED, A FOLLOW-UP REPORT WILL BE SENT.
Description of Event or Problem · 1
THE HEALTH CARE PROVIDER (HCP) CLARIFIED THAT THERE WAS NO ISSUE, THERE WAS NO UTI. THE PATIENT DID NOT HAVE AN INFECTION AND DID NOT HAVE A UTI.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 454026 | INTERSTIM | STIMULATOR, ELECTRICAL, IMPLANTABLE, FOR INCONTINENCE | EZW | MEDTRONIC NEUROMODULATION | NEU_ENS_STIMULATOR |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Required Intervention |