FDA Adverse Event
Injury
Summary report: N
INTERSTIM II
MDR report key: 1892259
·
Received November 2, 2010
Report
- Report Number
- 3004209178-2010-08732
- Event Type
- Injury
- Date Received
- November 2, 2010
- Date of Event
- January 1, 2010
- Report Date
- October 7, 2010
- 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
- TX, US
- Reporter Occupation
- NOT APPLICABLE
Narratives
Additional Manufacturer Narrative · 1
(B)(4).
Description of Event or Problem · 1
A PT'S IMPLANTED NEURO STIMULATOR UNDERWENT EROSION. THE PT'S DEVICE BATTERY WAS DETERMINED TO BE DEPLETED JUST PRIOR TO THE POCKET REVISION. IT WAS NOTED THAT THERE WAS NO KNOWN ACCIDENT OR INCIDENT THAT OCCURRED, THAT COULD BE RELATED TO THE ISSUE. THE PT'S STATUS WAS NOTED AS GOOD. NO FURTHER DETAILS WERE INDICATED AT THE TIME OF THIS REPORT. ADD'L INFO IS BEING REQUESTED FROM THE HCP, AND WILL BE PROVIDED IN A FOLLOW-UP REPORT AS IT BECOMES AVAILABLE.
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 | 50 YR | Required Intervention | LEAD: MODEL 3093, LOT# V067060| EXPLANTED:| IMPLANTED:| PROGRAMMER: MODEL 3037, LOT# NJD057023N| EXPLANTED:| IMPLANTED: |