FDA Adverse Event
Malfunction
Summary report: N
INTERSTIM II
MDR report key: 3071517
·
Received April 22, 2013
Report
- Report Number
- 3004209178-2013-06687
- Event Type
- Malfunction
- Date Received
- April 22, 2013
- Report Date
- April 3, 2013
- Manufacturer
- MEDTRONIC MED REL MEDTRONIC PUERTO RICO
- Product Code
- EZW
- PMA / PMN Number
- P970004
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- FL, US
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
(B)(4).
Additional Manufacturer Narrative · 1
(B)(4).
Additional Manufacturer Narrative · 1
CONCOMITANT PRODUCTS: PRODUCT ID 3889-28, LOT# V673560, IMPLANTED: (B)(6) 2011, PRODUCT TYPE LEAD; PRODUCT ID 3037, SERIAL# (B)(4), PRODUCT TYPE PROGRAMMER, PATIENT. (B)(4).
Description of Event or Problem · 1
IT WAS REPORTED THE PATIENT WAS THINKING OF GETTING THEIR IMPLANTABLE NEUROSTIMULATOR REMOVED AS IT HAD 'NEVER WORKED.' IT WAS STATED THAT THERE HAD BEEN MANY ATTEMPTS TO REPROGRAM THE DEVICE. IT WAS FURTHER INDICATED THE PATIENT DID NOT LIKE TO FLY WITH THE DEVICE. NO PATIENT SYMPTOMS WERE REPORTED. ADDITIONAL INFORMATION HAS BEEN REQUESTED, A FOLLOW UP REPORT WILL BE SENT IF ADDITIONAL INFORMATION IS RECEIVED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 172175 | INTERSTIM II | STIMULATOR, ELECTRICAL, IMPLANTABLE, FOR INCONTINENCE | EZW | MEDTRONIC MED REL MEDTRONIC PUERTO RICO | 3058 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |