FDA Adverse Event
Malfunction
Summary report: N
INTERSTIM II
MDR report key: 4110791
·
Received September 23, 2014
Report
- Report Number
- 3004209178-2014-17552
- Event Type
- Malfunction
- Date Received
- September 23, 2014
- Date of Event
- August 26, 2014
- Report Date
- August 27, 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
CONCOMITANT MEDICAL PRODUCTS: PRODUCT ID: 3037, SERIAL# (B)(4), PRODUCT TYPE: PROGRAMMER, PATIENT. PRODUCT ID: 3889-28, LOT# VA0LW7N, IMPLANTED: (B)(6) 2014, PRODUCT TYPE: LEAD. (B)(4).
Description of Event or Problem · 1
IT WAS REPORTED THE DEVICE WAS IMPLANTED AFTER THE USE BY DATE (UBD). NO ADDITIONAL INFORMATION ON PATIENT STATUS OR OUTCOME WAS REPORTED. IF ADDITIONAL INFORMATION IS RECEIVED, A FOLLOW-UP REPORT WILL BE SENT.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 589599 | INTERSTIM II | STIMULATOR, ELECTRICAL, IMPLANTABLE, FOR INCONTINENCE | EZW | MEDTRONIC MED REL MEDTRONIC PUERTO RICO | 3058 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 00031 YR |