FDA Adverse Event
Injury
Summary report: N
INTERSTIM II
MDR report key: 3000411
·
Received March 12, 2013
Report
- Report Number
- 3004209178-2013-03609
- Event Type
- Injury
- Date Received
- March 12, 2013
- Date of Event
- February 1, 2013
- Report Date
- February 20, 2013
- 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
- NJ, US
- Reporter Occupation
- PHYSICIAN
Narratives
Additional Manufacturer Narrative · 1
PRODUCT ID 3889-28, LOT# VA0451V, IMPLANTED: 2012-(B)(6), EXPLANTED: 2013-(B)(6), PRODUCT TYPE LEAD. (B)(4).
Description of Event or Problem · 1
IT WAS REPORTED THE PATIENT HAD THEIR DEVICE REMOVED DUE TO EROSION THROUGH THE SKIN. IT WAS STATED THE DEVICE BROKE THROUGH THE SKIN AFTER BEING IMPLANTED FOR 2 ½ MONTHS. THE PATIENT OUTCOME WAS REPORTED BY THE HEALTH CARE PROVIDER AS "NO INJURY." INFORMATION FROM THE PATIENT STATED THE PATIENT WAS "STILL HAVING CONCERNS" BUT WAS WORKING WITH THEIR HEALTH CARE PROVIDER.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 103303 | INTERSTIM II | STIMULATOR, ELECTRICAL, IMPLANTABLE, FOR INCONTINENCE | EZW | MEDTRONIC MED REL MEDTRONIC PUERTO RICO | 3058 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 00075 YR | Required Intervention |