FDA Adverse Event
Injury
Summary report: N
INTERSTIM
MDR report key: 4132768
·
Received October 1, 2014
Report
- Report Number
- 3007566237-2014-02795
- Event Type
- Injury
- Date Received
- October 1, 2014
- Report Date
- September 10, 2014
- Manufacturer
- MEDTRONIC NEUROMODULATION
- Product Code
- EZW
- PMA / PMN Number
- P970004
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- WA, US
- Reporter Occupation
- PATIENT
Narratives
Additional Manufacturer Narrative · 1
CONCOMITANT MEDICAL PRODUCTS: PRODUCT ID: NEU_UNKNOWN_LEAD, SERIAL# UNKNOWN, PRODUCT TYPE: LEAD. (B)(4).
Description of Event or Problem · 1
IT WAS REPORTED THAT THE PATIENT¿S IMPLANTABLE NEUROSTIMULATOR (INS) THAT WAS IMPLANTED IN THEIR SPINE IN 1991/92 AND THE NICKEL IN THE DEVICE CAUSED THEM TO HAVE A SEVERE REACTION AND HAD TO BE REMOVED. THE PATIENT STATED THAT THEY WERE ¿SEVERELY ALLERGIC¿ TO NICKEL. THERE WERE NO FURTHER DETAILS, INTERVENTIONS OR OUTCOME REPORTED REGARDING THIS EVENT. FURTHER FOLLOW-UP IS BEING CONDUCTED TO OBTAIN THIS INFORMATION. IF ADDITIONAL INFORMATION IS RECEIVED, A FOLLOW-UP REPORT WILL BE SENT.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 612018 | INTERSTIM | STIMULATOR, ELECTRICAL, IMPLANTABLE, FOR INCONTINENCE | EZW | MEDTRONIC NEUROMODULATION | NEU_INS_STIMULATOR |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Required Intervention |