SYNCHROMED
Report
- Report Number
- 3007566237-2010-07103
- Event Type
- Injury
- Date Received
- September 20, 2010
- Date of Event
- September 14, 2010
- Report Date
- September 14, 2010
- Manufacturer
- MEDTRONIC NEUROMODULATION
- Product Code
- LKK
- PMA / PMN Number
- P860004
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- MN, US
- Reporter Occupation
- PHYSICIAN
Narratives
(B)(4). IT WAS NOT POSSIBLE TO ASCERTAIN SPECIFIC DEVICE INFORMATION FROM THE ARTICLE OR TO MATCH THE EVENTS REPORTED WITH PREVIOUSLY REPORTED EVENTS. THE PATIENT INFORMATION PROVIDED IN SECTION A IS THE AVERAGE FOR ALL THE PATIENTS. AT THIS TIME NO ADDITIONAL INFORMATION WAS AVAILABLE; FOLLOW UP HAS BEEN REQUESTED.
LITERATURE: QUINN SS, KRACH LE, WENDORF HR. INTRATHECAL BACLOFEN PUMPS: A REVIEW OF ADVERSE EVENTS AT (B)(6) CHILDREN'S SPECIALTY HEALTHCARE, 1996-1997 AND 2005-2006. SCIENTIFIC POSTER 36. SUMMARY: THE PURPOSE OF THIS STUDY IS TO COMPARE THE TYPE AND FREQUENCY OF ADVERSE EVENTS OVER A 2 YEAR PERIOD FOR INDIVIDUALS WITH INITIAL PUMP PLACEMENT IN 1996-1997 TO THOSE WITH INITIAL PLACEMENT IN 2005-2006. STUDY INCLUDED ALL PATIENTS WHO UNDERWENT INITIAL BACLOFEN PUMP AND CATHETER PLACEMENT FOR TONE MANAGEMENT AT A SPECIALTY CENTER FOR CHILDREN AND ADULTS WITH DISABILITIES FROM 1996-1997 (GROUP I, N=49) AND FROM 2005-2006 (GROUP II, N=45). MEDIAN AGE WAS 8 YEARS. THERE WAS 54 MALES AND 40 FEMALES. EVENT: THERE WERE A TOTAL OF SEVEN DEEP INFECTIONS, 3 IN GROUP 1 (6%) AND 4 IN GROUP II (9%). ALL REQUIRED PUMP EXPLANT. SIX PATIENTS IN GROUP I (12%) AND FIVE IN GROUP II (11%) REQUIRED CATHETER REVISION OR REPLACEMENT. ONLY ONE PATIENT HAD A PUMP COMPLICATION.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | SYNCHROMED | LKK | MEDTRONIC NEUROMODULATION | PUMP | NA |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 8 YR | Required Intervention | CATHETER UNK| PROGRAMMER UNK |