FDA Adverse Event
Injury
Summary report: N
INTERSTIM
MDR report key: 1895303
·
Received November 8, 2010
Report
- Report Number
- 3007566237-2010-09042
- Event Type
- Injury
- Date Received
- November 8, 2010
- Date of Event
- September 22, 2010
- Report Date
- October 18, 2010
- Manufacturer
- MEDTORNIC NEUROMODULATION
- Product Code
- EZW
- PMA / PMN Number
- P970004
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Occupation
- PHYSICIAN
Narratives
Additional Manufacturer Narrative · 1
(B)(4) .
Description of Event or Problem · 1
IT WAS REPORTED THAT THE PT EXPERIENCED AN OPENED SUTURE AND THE INCISION SITE FOR THE POCKET WAS COMPROMISED. DEHISCENCE WAS PRESENT THE ENTIRE DEPTH OF THE POCKET EXTENDING TO THE LEAD AND AT THE LEAD INTRODUCER SITE. AS A RESULT, THE LEAD WAS EXPLANTED AND THE PT RECOVERED WITHOUT SEQUELAE. ADDITIONAL INFORMATION HAS BEEN REQUESTED AND WILL BE MADE AS FOLLOW UP AS IT BECOMES AVAILABLE.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | INTERSTIM | EZW | MEDTORNIC NEUROMODULATION | IPG URO | NA |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Required Intervention | IMPLANTED:| LEAD: MODEL LEAD URO, LOT# UNK| EXPLANTED: |