FDA Adverse Event
Injury
Summary report: N
SYNCHROMED
MDR report key: 884803
·
Received July 24, 2007
Report
- Report Number
- 2182207-2007-02313
- Event Type
- Injury
- Date Received
- July 24, 2007
- Report Date
- May 12, 2005
- Manufacturer
- NEUROLOGICAL DIVISION, MEDTRONIC INC
- Product Code
- LKK
- PMA / PMN Number
- P860004
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Occupation
- PHYSICIAN
Narratives
Additional Manufacturer Narrative · 1
.
Description of Event or Problem · 1
BURCHIEL, KJ; COMMENTS ON ARTICLE BY TAHA ET AL: CORRELATION BETWEEN WITHDRAWAL SYMPTOMS AND MEDICATION PUMP RESIDUAL VOLUME IN PTS WITH IMPLANTABLE SYNCHROMED PUMPS. COMMENTS NEUROSURGERY. 2004; 55, 2: 393-394. COMMENTS REFERENCING 10% OF THEIR PTS EXPERIENCE MEDICATION WITHDRAWAL BEFORE THE PUMP REACHED 2 ML. (THE MANUFACTURER'S RECOMMENDED ALARM REFILL VOLUME SETTING).
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | SYNCHROMED | LKK | NEUROLOGICAL DIVISION, MEDTRONIC INC | PUMP | NA |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | YR | Required Intervention | PROGRAMMER MODEL PROGRAMMER LOT # UNK| IMPLANTED| EXPLANTED| IMPLANTED| EXPLANTED| CATHETER MODEL CATHETER LOT UNK |