FDA Adverse Event
Injury
Summary report: N
SYNCHROMED II
MDR report key: 1062908
·
Received June 19, 2008
Report
- Report Number
- 3004209178-2008-03361
- Event Type
- Injury
- Date Received
- June 19, 2008
- Report Date
- May 21, 2008
- Manufacturer
- MEDTRONIC PUERTO RICO OPERATIONS CO.
- Product Code
- LKK
- PMA / PMN Number
- P860004
- Adverse Event
- Yes
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- MN, US
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
THIS REPORT REFERS TO THE MODEL 8709 CATHETER. PRELIMINARY DEVICE ANALYSIS WAS NOT AVAILABLE ON THE DATE OF THIS REPORT. A FOLLOW UP REPORT WILL BE SUBMITTED WHEN DEVICE ANALYSIS IS COMPLETED.
Description of Event or Problem · 1
THE PATIENT'S INTRATHECAL DRUG DELIVERY CATHETER WAS EXPLANTED AND RETURNED TO THE MANUFACTURER BECAUSE THE CONNECTING PORTION OF THE CATHETER WAS LEAKING FROM A PIN HOLE. NO PT SYMPTOMS WERE REPORTED. THE PT RECOVERED WITHOUT SEQUELA. THE DRUG USED IN THE PUMP WAS NOT REPORTED. ADDITIONAL INFO HAS BEEN REQUESTED, BUT WAS NOT AVAILABLE AS OF THE DATE OF THIS REPORT.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | SYNCHROMED II | LKK | MEDTRONIC PUERTO RICO OPERATIONS CO. | 863720 | NA |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Required Intervention | IMPLANTED:| IMPLANTED:| EXPLANTED:| PROGRAMMER MODEL PROGRAMMER LOT# UNK| CATHETER MODEL 8709| EXPLANTED:| CATHETER MODEL 8711 LOT# N080866013 |