FDA Adverse Event
Injury
Summary report: N
INTERSTIM II
MDR report key: 3418826
·
Received October 18, 2013
Report
- Report Number
- 3004209178-2013-19336
- Event Type
- Injury
- Date Received
- October 18, 2013
- Report Date
- September 25, 2013
- Manufacturer
- MEDTRONIC MED REL MEDTRONIC PUERTO RICO
- Product Code
- EZW
- PMA / PMN Number
- P080025
- Adverse Event
- Yes
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- IN, US
- Reporter Occupation
- PHYSICIAN
Narratives
Additional Manufacturer Narrative · 1
PRODUCT ID 3037 LOT# SERIAL# (B)(4); PRODUCT TYPE PROGRAMMER, PATIENT. (B)(4).
Additional Manufacturer Narrative · 1
PMA 510(K): ADDED MISSING PMA NUMBER.
Description of Event or Problem · 1
IT WAS REPORTED, THE PATIENT HAD STIMULATION IN THE WRONG LOCATION AND THEIR LEAD WAS REPLACED. IT WAS STATED, THE PATIENT TOLD THEIR PHYSICIAN THAT THE STIMULATION LOCATION HAD CHANGED AND THEY WANTED THE LEAD REPLACED. IT WAS NOTED, THE ISSUE WAS RESOLVED AND THE PATIENT¿S OUTCOME WAS REPORTED AS NO INJURY. IT WAS STATED THERE WERE NO PATIENT SYMPTOMS OR COMPLICATIONS ASSOCIATED WITH THE EVENT.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 535029 | INTERSTIM II | STIMULATOR, ELECTRICAL, IMPLANTABLE, FOR INCONTINENCE | EZW | MEDTRONIC MED REL MEDTRONIC PUERTO RICO | 3058 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Required Intervention |