FDA Adverse Event
Injury
Summary report: N
INTERSTIM
MDR report key: 2133552
·
Received June 15, 2011
Report
- Report Number
- 9614453-2011-04432
- Event Type
- Injury
- Date Received
- June 15, 2011
- Date of Event
- May 1, 2011
- Report Date
- October 18, 2011
- Manufacturer
- MEDTRONIC EUROPE SARL
- Product Code
- EZW
- PMA / PMN Number
- P970004
- Adverse Event
- Yes
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- SZ
- Reporter Occupation
- PHYSICIAN
Narratives
Additional Manufacturer Narrative · 1
(B)(4).
Description of Event or Problem · 1
ADDITIONAL INFORMATION RECEIVED REPORTED THAT THE LEAD WAS REPLACED DUE TO A BREAK. THE HCP RATED THE BREAK AS NORMAL.
Description of Event or Problem · 1
THE PT HAD HER LEAD REPLACED. THE REASON FOR REPLACEMENT WAS NOT PROVIDED. IT WAS UNCLEAR IF THE IMPLANTABLE NEUROSTIMULATOR WAS REPLACED AS WELL. THE PT WAS NOT INJURED AND WAS DOING WELL WITH THE NEW LEAD. ADDITIONAL INFORMATION HAS BEEN REQUESTED, A F/U REPORT WILL BE SENT IF ADDITIONAL INFORMATION BECOMES AVAILABLE.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | INTERSTIM | STIMULATOR, ELECTRICAL, IMPLANTABLE, FOR INCONTINENCE | EZW | MEDTRONIC EUROPE SARL | 3023 | NA |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Required Intervention | LEAD: MODEL 3889, LOT # 0203318784| IMPLANTED:| EXPLANTED: |