FDA Adverse Event
Injury
Summary report: N
INTERSTIM II
MDR report key: 1091504
·
Received August 1, 2008
Report
- Report Number
- 3004209178-2008-04525
- Event Type
- Injury
- Date Received
- August 1, 2008
- Date of Event
- May 1, 2008
- Report Date
- June 12, 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
- MN, US
- Reporter Occupation
- NOT APPLICABLE
Narratives
Description of Event or Problem · 1
IT WAS REPORTED THAT DURING SURGICAL REVISION OF THE DEVICE, ELECTROCAUTERY WAS USED TOO CLOSELY TO THE IPG, CAUSING A POWER ON RESET CONDITION AND ERROR MESSAGE WHEN THE PT ATTEMPTED TO ADJUST HER STIMULATION. THE PATIENT DID NOT BRING HER PATIENT PROGRAMMER TO THE SURGERY, SO IT WAS NOT SYNCHED, CAUSING IT TO NOT BE ABLE TO COMMUNICATE WITH THE IPG. THE REASON FOR THE SURGICAL REVISION IS UNKNOWN. FURTHER INFO IS BEING REQUESTED FROM THE HCP.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | INTERSTIM II | EZW | MEDTRONIC PUERTO RICO OPERATIONS CO | 3058 | NA |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Required Intervention | EXPLANTED| LEAD MODEL 3093| PROGRAMMER MODEL 3037| IMPLANTED |