FDA Adverse Event
Malfunction
Summary report: N
INTERSTIM
MDR report key: 3192593
·
Received June 27, 2013
Report
- Report Number
- 9614453-2013-01458
- Event Type
- Malfunction
- Date Received
- June 27, 2013
- Report Date
- July 16, 2012
- Manufacturer
- MEDTRONIC NEUROMODULATION
- Product Code
- EZW
- PMA / PMN Number
- P080025
- Adverse Event
- Yes
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- UK
- Reporter Occupation
- HEALTH PROFESSIONAL
Narratives
Additional Manufacturer Narrative · 1
PRODUCT ID 309328, LOT# B0398913K, IMPLANTED: 2006-(B)(6), PRODUCT TYPE LEAD PRODUCT ID 3095-10, SERIAL# (B)(4), IMPLANTED: 2006-(B)(6), PRODUCT TYPE EXTENSION. (B)(4).
Additional Manufacturer Narrative · 1
THE INITIAL MDR WAS FILED AS MFR REPORT # 9614453-2013-01458. ADDITIONAL REVIEW INDICATED THE CORRECT MANUFACTURING SITE WAS SITE 3004209178.
Description of Event or Problem · 1
IT WAS REPORTED THAT THE PATIENT EXPERIENCED ¿ELECTRIC SHOCK¿ AND PAIN RUNNING DOWN THE LEFT LEG FROM THE SITE OF STIMULATION. THE IMPLANT WAS SUBSEQUENTLY TURNED OFF. THE DEVICE WAS RESTARTED AND REPROGRAMMED. NO FURTHER ADVERSE STIMULATION WAS NOTED. THE ISSUE RESOLVED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 293956 | INTERSTIM | STIMULATOR, ELECTRICAL, IMPLANTABLE, FOR INCONTINENCE | EZW | MEDTRONIC NEUROMODULATION | NEU_INS_STIMULATOR |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 00046 YR |