FDA Adverse Event
Injury
Summary report: N
INTERSTIM II
MDR report key: 2031521
·
Received March 25, 2011
Report
- Report Number
- 3004209178-2011-02128
- Event Type
- Injury
- Date Received
- March 25, 2011
- Date of Event
- March 9, 2011
- Report Date
- March 10, 2011
- Manufacturer
- MDT PUERTO RICO OPERATIONS CO., JUNCOS
- Product Code
- EZW
- PMA / PMN Number
- P970004
- Adverse Event
- Yes
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- CA, US
- Reporter Occupation
- NOT APPLICABLE
Narratives
Additional Manufacturer Narrative · 1
(B)(4).
Description of Event or Problem · 1
A POWER-ON-RESET (POR) CONDITION WAS REPORTED ON THE PT'S NEUROSTIMULATOR FOLLOWING A REVISION PROCEDURE TO REPOSITION THE DEVICE DUE TO PAIN AT THE POCKET. THE PHYSICIAN WAS UNABLE TO RELOCATE THE DEVICE DUE TO SCAR TISSUE. THE STIMULATION WAS TESTED POST-PROCEDURE AND THE PT NOTED THE POR WHEN SHE TURNED THE DEVICE ON AT HOME. ADDITIONAL INFO WAS REQUESTED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | INTERSTIM II | EZW | MDT PUERTO RICO OPERATIONS CO., JUNCOS | 3058 | NA |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 40 YR | Required Intervention | EXPLANTED:| LEAD: MODEL 3093, LOT# V430989| IMPLANTED: |