FDA Adverse Event
Malfunction
Summary report: N
INTERSTIM II
MDR report key: 3864264
·
Received June 10, 2014
Report
- Report Number
- 3004209178-2014-11309
- Event Type
- Malfunction
- Date Received
- June 10, 2014
- Report Date
- May 19, 2014
- Manufacturer
- MEDTRONIC MED REL MEDTRONIC PUERTO RICO
- 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
(B)(4).
Description of Event or Problem · 1
IT WAS REPORTED THAT MANUFACTURER REPRESENTATIVE WAS ON A CASE 2 DAYS PRIOR TO THIS CALL WHEN HE TOOK THE NEUROSTIMULATOR OUT OF HIS TRUNK STOCK. WHEN THE HEALTH CARE PROVIDER OPENED IT AND TRIED TO SCREW IT IN (ONLY GOING FORWARD), IT WAS OUT OF ITS GROVE AND WOULD NOT SCREW DOWN. IT WAS INDICATED THAT THE DEVICE WAS NOT IMPLANTED. A FOLLOW-UP REPORT WILL BE SENT IF ADDITIONAL INFORMATION BECOMES AVAILABLE.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 337627 | INTERSTIM II | STIMULATOR, ELECTRICAL, IMPLANTABLE, FOR INCONTINENCE | EZW | MEDTRONIC MED REL MEDTRONIC PUERTO RICO | 3058 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |