FDA Adverse Event
Injury
Summary report: N
INTERSTIM II
MDR report key: 3426201
·
Received October 23, 2013
Report
- Report Number
- 3004209178-2013-19584
- Event Type
- Injury
- Date Received
- October 23, 2013
- Report Date
- October 3, 2013
- Manufacturer
- MEDTRONIC MED REL MEDTRONIC PUERTO RICO
- Product Code
- EZW
- PMA / PMN Number
- P970004
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- MA, US
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
PRODUCT ID 3093-28 LOT# V203110, IMPLANTED: 2009 (B)(6); PRODUCT TYPE LEAD PRODUCT ID 3093-28 LOT# V203110, IMPLANTED: 2009 (B)(6); PRODUCT TYPE LEAD (B)(4).
Additional Manufacturer Narrative · 1
(B)(4).
Description of Event or Problem · 1
IT WAS REPORTED, THE PATIENT¿S FIRST IMPLANTABLE NEUROSTIMULATOR (INS) WAS ¿FAULTY.¿ IT WAS STATED, THE PATIENT¿S DOCTOR HAD THE INS ANALYZED AND IT WAS DETERMINED THAT THERE WAS A FAULTY LEAD WIRE THAT CAUSED THEIR DEVICE TO RUN OUT OF BATTERY EARLY.
Description of Event or Problem · 1
ADDITIONAL INFORMATION RECEIVED FROM DOCTOR'S OFFICE. IN THE DOCTOR'S NOTES IT WAS MENTIONED ON (B)(6), 2012 THAT THE PATIENT WAS UNABLE TO FEEL HER STIMULATION AT THAT TIME. NOTHING WAS NOTED ABOUT A FAULTY WIRE. IT WAS NOTED THERE WAS A DEPLETED INTERSTIM BATTERY.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 543511 | INTERSTIM II | STIMULATOR, ELECTRICAL, IMPLANTABLE, FOR INCONTINENCE | EZW | MEDTRONIC MED REL MEDTRONIC PUERTO RICO | 3058 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 00072 YR | Required Intervention |