FDA Adverse Event
Injury
Summary report: N
INTERSTIM
MDR report key: 1190327
·
Received October 6, 2008
Report
- Report Number
- 3004209178-2008-06353
- Event Type
- Injury
- Date Received
- October 6, 2008
- Date of Event
- July 17, 2008
- Report Date
- September 8, 2008
- Manufacturer
- MEDTRONIC PUERTO RICO OPERATIONS CO.
- Product Code
- EZW
- PMA / PMN Number
- P970004
- Adverse Event
- Yes
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- SC, US
- Reporter Occupation
- PHYSICIAN
Narratives
Additional Manufacturer Narrative · 1
FINAL DEVICE ANALYSIS WAS NOT AVAILABLE AT THE TIME OF THIS REPORT. A FOLLOW-UP MEDWATCH REPORT WILL BE SENT WHEN THE ANALYSIS IS COMPLETE AND/OR WHEN ADDITIONAL INFO IS RECEIVED FROM THE HCP.
Description of Event or Problem · 1
IT WAS REPORTED THAT THE LEAD IMPEDANCE MEASUREMENT WAS GREATER THAN 4,000 OHMS. THE IMPLANTED NEUROSTIMULATOR, LEAD AND EXTENSION WERE REPLACED FURTHER INFO IS BEING REQUESTED FROM THE HCP.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | INTERSTIM | EZW | MEDTRONIC PUERTO RICO OPERATIONS CO. | 3023 | NA |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Required Intervention | PROGRAMMER MODEL 3031A LOT# NGM028836P| EXPLANTED| EXPLANTED| EXTENSION MODEL 3095 LOT# NAH033228V IMPLANTED| LEAD MODEL LEAD LOT#UNKNOWN IMPLANTED |