FDA Adverse Event
Malfunction
Summary report: N
INTERSTIM II
MDR report key: 3870330
·
Received June 12, 2014
Report
- Report Number
- 3004209178-2014-11503
- Event Type
- Malfunction
- Date Received
- June 12, 2014
- Report Date
- May 22, 2014
- Manufacturer
- MEDTRONIC MED REL MEDTRONIC PUERTO RICO
- Product Code
- EZW
- PMA / PMN Number
- P970004
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- MI, US
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
CONCOMITANT MEDICAL PRODUCTS: PRODUCT ID 3889-28, LOT# V390203, IMPLANTED: (B)(6) 2010, PRODUCT TYPE: LEAD; PRODUCT ID 3037, SERIAL# (B)(4), PRODUCT TYPE: PROGRAMMER, PATIENT; PRODUCT ID NEU_UNKNOWN_LEAD, SERIAL# UNKNOWN, PRODUCT TYPE: LEAD; PRODUCT ID 3889-28, LOT# V390203, IMPLANTED: (B)(6) 2010, PRODUCT TYPE: LEAD. (B)(4).
Description of Event or Problem · 1
IT WAS REPORTED THAT THE PATIENT WAS TOLD THAT SHE WAS IMPLANTED WITH 2 WIRES, BUT ONE BECAME DISLODGED A DAY OR TWO AFTER SURGERY. IT WAS STATED THAT THE LEAD WAS NEVER REMOVED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 347067 | INTERSTIM II | STIMULATOR, ELECTRICAL, IMPLANTABLE, FOR INCONTINENCE | EZW | MEDTRONIC MED REL MEDTRONIC PUERTO RICO | 3058 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 00075 YR |