FDA Adverse Event
Injury
Summary report: N
INTERSTIM II
MDR report key: 2854498
·
Received December 3, 2012
Report
- Report Number
- 3004209178-2012-11053
- Event Type
- Injury
- Date Received
- December 3, 2012
- Report Date
- November 6, 2012
- 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
- NY, US
- Reporter Occupation
- PHYSICIAN
Narratives
Additional Manufacturer Narrative · 1
PRODUCT ID 3889-28. LOT # V884818, IMPLANTED: (B)(6) 2012, EXPLANTED: (B)(6) 2012, PRODUCT TYPE LEAD; PRODUCT ID 3037, SERIAL # (B)(4), PRODUCT TYPE PROGRAMMER.(B)(4).
Description of Event or Problem · 1
IT WAS REPORTED THAT A PATIENT HAD LEFT BACK AND SCIATIC PAIN FROM THE DEVICE. THE REPORTER STATED THAT THE LEAD TWISTED ON ITSELF. IT WAS NOTED THAT REPROGRAMMING WAS PERFORMED ON (B)(6) 2012, WITH PROGRAM 1 AMPLITUDE AT 0.7. IT WAS REPORTED THAT THE PATIENT FELT THE STIMULATION VAGINALLY WITH PAIN IN THE LEFT BUTTOCK AND LEG. THE REPORTER STATED THAT A REVISION WAS PERFORMED ON (B)(6) 2012 WHEN THE EXISTING LEAD WAS REMOVED AND A NEW LEAD WAS PLACED. IT WAS NOTED THAT THE PAIN WAS RESOLVED, NO HOSPITALIZATION WAS REQUIRED, AND THE PATIENT OUTCOME WAS REPORTED AS NO INJURY.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | INTERSTIM II | STIMULATOR, ELECTRICAL, IMPLANTABLE, FOR INCONTINENCE | EZW | MEDTRONIC MED REL MEDTRONIC PUERTO RICO | 3058 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Required Intervention |