FDA Adverse Event
Malfunction
Summary report: N
INTERSTIM
MDR report key: 3222499
·
Received July 12, 2013
Report
- Report Number
- 6000153-2013-00133
- Event Type
- Malfunction
- Date Received
- July 12, 2013
- Date of Event
- June 17, 2013
- Report Date
- August 16, 2018
- Manufacturer
- NEURO - VILLALBA
- Product Code
- EZW
- PMA / PMN Number
- P970004
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- FR
- Reporter Occupation
- HEALTH PROFESSIONAL
Narratives
Additional Manufacturer Narrative · 1
(B)(4).
Additional Manufacturer Narrative · 1
IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.
Description of Event or Problem · 1
IT WAS REPORTED THAT IT WAS IMPOSSIBLE TO COMPLETELY INSERT THE LEAD INTO THE IMPLANTABLE NEUROSTIMULATOR (INS). THE HEALTH CARE PROVIDER (HCP) THOUGHT IT WAS A MATTER WITH THE DIAMETER OF THE BLUE END OF THE LEAD. THE HCP DECIDED TO CUT THE BLUE END PART AND DID NOT HAVE A PROBLEM INSERTING THE LEAD. THERE WAS NO CONSEQUENCE TO THE PATIENT.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 322348 | INTERSTIM | STIMULATOR, ELECTRICAL, IMPLANTABLE, FOR INCONTINENCE | EZW | NEURO - VILLALBA | 309328 | VA0540F |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 00029 YR |