FDA Adverse Event
Injury
Summary report: N
INTERSTIM II
MDR report key: 3833726
·
Received May 27, 2014
Report
- Report Number
- 3004209178-2014-09661
- Event Type
- Injury
- Date Received
- May 27, 2014
- Report Date
- April 30, 2014
- 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
- FL, US
- Reporter Occupation
- PHYSICIAN
Narratives
Additional Manufacturer Narrative · 1
CONCOMITANT MEDICAL PRODUCTS: PRODUCT ID 3093-28, LOT# V091642, IMPLANTED: 2008-(B)(6), EXPLANTED: 2013-(B)(6), PRODUCT TYPE LEAD. (B)(4).
Description of Event or Problem · 1
IT WAS REPORTED THE PATIENT¿S IMPLANT JUST BECAME INEFFECTIVE. IT WAS NOTED THERE WERE NO ABNORMAL IMPEDANCE MEASUREMENTS. IT WAS REPORTED THE PATIENT¿S DEVICE WAS EXPLANTED ON (B)(6)-2013 AND A SECOND STAGE IMPLANT WAS PLACED ON THE PATIENT¿S OPPOSITE SIDE, THEIR RIGHT SIDE. IT WAS NOTED THE PATIENT¿S OLD IMPLANT WENT TO THE LEFT SACRAL FORAMEN. IT WAS STATED THE PATIENT HAD RECURRENT PROGRAMMING OF REFRACTORY OVER ACTIVE BLADDER. REPORTEDLY, THE PATIENT DID NOT REQUIRE HOSPITALIZATION.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 310098 | INTERSTIM II | STIMULATOR, ELECTRICAL, IMPLANTABLE, FOR INCONTINENCE | EZW | MEDTRONIC MED REL MEDTRONIC PUERTO RICO | 3058 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 00068 YR | Required Intervention |