FDA Adverse Event
Injury
Summary report: N
INTERSTIM II
MDR report key: 3695670
·
Received March 24, 2014
Report
- Report Number
- 3004209178-2014-04903
- Event Type
- Injury
- Date Received
- March 24, 2014
- Date of Event
- February 1, 2012
- Report Date
- February 28, 2014
- Manufacturer
- MEDTRONIC MED REL MEDTRONIC PUERTO RICO
- Product Code
- EZW
- PMA / PMN Number
- P970004
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- TN, US
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
CONCOMITANT PRODUCTS: PRODUCT ID 3093-28 LOT# V850461, IMPLANTED: (B)(6) 2012, EXPLANTED: (B)(6) 2013, PRODUCT TYPE LEAD; PRODUCT ID 3037, SERIAL # (B)(4), PRODUCT TYPE PROGRAMMER, PATIENT; PRODUCT ID 3093-28, LOT # V850461, IMPLANTED: (B)(6) 2012, EXPLANTED: (B)(6) 2013, PRODUCT TYPE LEAD. (B)(4).
Additional Manufacturer Narrative · 1
(B)(4).
Description of Event or Problem · 1
IT WAS REPORTED THE PATIENT¿S SYSTEM STOPPED WORKING AND HAD IT REPLACED. IT WAS NOTED THE NEUROSTIMULATOR HAD BLOOD ON IT, SO IT WAS ALSO REPLACED. IT WAS REPORTED THE WIRES WERE PLACED ON THE OPPOSITE SIDE. IT WAS NOTED THE DEVICE NEVER WORKED, BUT THE TRIAL DID.
Description of Event or Problem · 1
IT WAS REPORTED THE PATIENT¿S WIRES STOPPED WORKING AND HAD THEM REPLACED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 171642 | INTERSTIM II | STIMULATOR, ELECTRICAL, IMPLANTABLE, FOR INCONTINENCE | EZW | MEDTRONIC MED REL MEDTRONIC PUERTO RICO | 3058 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 00070 YR | Required Intervention |