FDA Adverse Event
Injury
Summary report: N
INTERSTIM II
MDR report key: 4840798
·
Received June 12, 2015
Report
- Report Number
- 3004209178-2015-11528
- Event Type
- Injury
- Date Received
- June 12, 2015
- Report Date
- May 25, 2015
- Manufacturer
- MEDTRONIC MED REL MEDTRONIC PUERTO RICO
- Product Code
- EZW
- PMA / PMN Number
- P970004
- Adverse Event
- Yes
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- MN, US
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
CONCOMITANT PRODUCTS: PRODUCT ID 3889-28, LOT # V151684, IMPLANTED: (B)(6) 2008, EXPLANTED: (B)(6) 2015, PRODUCT TYPE LEAD; PRODUCT ID 3037, SERIAL # (B)(4), IMPLANTED: (B)(6) 2008, PRODUCT TYPE PROGRAMMER, PATIENT. (B)(4).
Description of Event or Problem · 1
IT WAS INDICATED THAT THE PATIENT HAD A TOTAL REVISION. THERE WAS LEAD IMPEDANCE AND THE BATTERY LIFE WAS LOW SO WE REVISED THE ENTIRE SYSTEM. NO OUTCOME WAS REPORTED REGARDING THIS EVENT. A FURTHER FOLLOW-UP IS BEING CONDUCTED TO OBTAIN THIS INFORMATION. A FOLLOW-UP REPORT WILL BE SENT IF ADDITIONAL INFORMATION BECOMES AVAILABLE.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 386381 | INTERSTIM II | STIMULATOR, ELECTRICAL, IMPLANTABLE, FOR INCONTINENCE | EZW | MEDTRONIC MED REL MEDTRONIC PUERTO RICO | 3058 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 00074 YR | Required Intervention |