FDA Adverse Event
Injury
Summary report: N
INTERSTIM II
MDR report key: 2520381
·
Received April 6, 2012
Report
- Report Number
- 3004209178-2012-02162
- Event Type
- Injury
- Date Received
- April 6, 2012
- Report Date
- April 3, 2012
- Manufacturer
- MEDTRONIC MED REL MEDTRONIC PUERTO RICO
- Product Code
- EZW
- PMA / PMN Number
- P970004
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- KY, US
- Reporter Occupation
- PATIENT
Narratives
Additional Manufacturer Narrative · 1
PROGRAMMER: MODEL 3037 SERIAL# (B)(4), LEAD MODEL 3889-33, LOT# V132935, IMPLANTED: (B)(6) 2008, EXPLANTED: UNK. (B)(4).
Description of Event or Problem · 1
IT WAS REPORTED THAT THE PATIENT EXPERIENCED PAIN DOWN THEIR ARMS, HIPS AND LEGS. THE CAUSE OF THE EVENT WAS UNKNOWN TO THE HEALTH CARE PROVIDER. MEDICAL IMAGING WAS USED AND THE LEAD APPEARED NORMAL. THE DEVICE WAS EXPLANTED AND THE PATIENT'S PAIN WENT AWAY. IT WAS NOTED THAT THERE WAS NO INJURY TO THE PATIENT. IF ADDITIONAL INFORMATION BECOMES AVAILABLE, A FOLLOW-UP REPORT WILL BE SENT.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | INTERSTIM II | STIMULATOR, ELECTRICAL, IMPLANTABLE, FOR INCONTINENCE | EZW | MEDTRONIC MED REL MEDTRONIC PUERTO RICO | 3058 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Required Intervention |