FDA Adverse Event
Malfunction
Summary report: N
INTERSTIM II
MDR report key: 3843351
·
Received June 2, 2014
Report
- Report Number
- 3004209178-2014-09962
- Event Type
- Malfunction
- Date Received
- June 2, 2014
- Date of Event
- May 12, 2014
- Report Date
- May 12, 2014
- Manufacturer
- MEDTRONIC PUERTO RICO OPERATIONS CO.
- Product Code
- EZW
- PMA / PMN Number
- P970004
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- MN, US
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
CONCOMITANT PRODUCT: PRODUCT ID NEU_UNKNOWN_LEAD, LOT# UNKNOWN, PRODUCT TYPE LEAD. (B)(4).
Description of Event or Problem · 1
ADDITIONAL INFORMATION RECEIVED REPORTED THAT THE MANUFACTURER REPRESENTATIVE GAVE THE ACCOUNT THE RETURN MAILER KIT.
Description of Event or Problem · 1
IT WAS REPORTED THAT THE LEAD WOULD NOT SEAT INTO THE IMPLANTABLE NEUROSTIMULATOR (INS) CONNECTOR BLOCK. THE MANUFACTURER REPRESENTATIVE TRIED SEVERAL DIFFERENT TECHNIQUES WITH NO SUCCESS. IT WAS NOTED THAT ANOTHER INS WAS USED WITH NO ISSUES. THE MANUFACTURER REPRESENTATIVE WAS CALLING POST-IMPLANT AND THE IMPLANT HAPPENED IN THE MORNING. IT WAS REPORTED THAT THEY WOULD SEND THE INS BACK IN.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 321435 | INTERSTIM II | STIMULATOR, ELECTRICAL, IMPLANTABLE, FOR INCONTINENCE | EZW | MEDTRONIC PUERTO RICO OPERATIONS CO. | 3058 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |