FDA Adverse Event
Malfunction
Summary report: N
SYNCHROMED II
MDR report key: 1030943
·
Received April 17, 2008
Report
- Report Number
- 2182207-2008-02041
- Event Type
- Malfunction
- Date Received
- April 17, 2008
- Date of Event
- March 1, 2008
- Report Date
- March 18, 2008
- Manufacturer
- MEDTRONIC NEUROMODULATION
- Product Code
- LKK
- PMA / PMN Number
- P860004
- Adverse Event
- Yes
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- CA
- Reporter Occupation
- PHYSICIAN
Narratives
Additional Manufacturer Narrative · 1
.
Description of Event or Problem · 1
IT WAS REPORTED THAT A NEWLY IMPLANTED PUMP HAD FLIPPED. THE FLIP WAS NOTICED AT THE FIRST REFILL VISIT AND WAS CONFIRMED BY X-RAY OR COMPUTERIZED TOMOGRAPHY. THE PATIENT HAD NO SYMPTOMS. IT WAS REPORTED THAT THERE WERE PUMP IMPLANT TECHNIQUE ISSUES (NOT SPECIFIED). A PUMP REVISION SURGERY WAS SCHEDULED. THE PUMP WAS USED TO DELIVER LIORESAL. ADDITIONAL INFORMATION HAS BEEN REQUESTED, A FOLLOW-UP REPORT WILL BE SUBMITTED IF ADDITIONAL INFORMATION BECOMES AVAILABLE.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | SYNCHROMED II | LKK | MEDTRONIC NEUROMODULATION | 8637 | NA |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Required Intervention | CATHETER MODEL 8731SC LOT# B0487081K| PROGRAMMER MODEL 8840 LOT# UNKNOWN| IMPLANTED:| EXPLANTED:| EXPLANTED:| IMPLANTED: |