FDA Adverse Event
Injury
Summary report: N
INTRATHECAL CATHETER
MDR report key: 1021090
·
Received March 27, 2008
Report
- Report Number
- 2182207-2008-01618
- Event Type
- Injury
- Date Received
- March 27, 2008
- Report Date
- March 4, 2008
- Manufacturer
- MEDTRONIC NEUROMODULATION
- Product Code
- LKK
- PMA / PMN Number
- P860004
- Adverse Event
- Yes
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- MI, US
- Reporter Occupation
- PHYSICIAN
Narratives
Additional Manufacturer Narrative · 1
.
Description of Event or Problem · 1
JOURNAL REFERENCE: ROOSEN ET AL. "ANALYSIS OF SURGICAL INTRATHECAL (I.T.) BACLOFEN (ITB) IMPLANT RESULTS EMPHASIZING REVISION SURGERY IN A MIXED PEDIATRIC/ADULT POPULATION." P54, PROGRAM AND ABSTRACTS, CHILD NEUROLOGY SOCIETY. P S121.THE AUTHORS PROVIDED A RETROSPECTIVE REVIEW OF REVISION SURGERY EXPERIENCED FOR PRIMARY IMPLANTS (IMPLANTED AT THEIR INSTITUTION) AND OPERATIVE REVISIONS FOR CASES ORIGINALLY IMPLANTED OUTSIDE THEIR INSTITUTION. SINCE 2002, THEY TREATED 41 PTS, 15 WHICH REQUIRED VARIOUS REVISIONS. REPORTABLE EVENT: 1 PT WITH SLOWLY INCREASING BACLOFEN-RESISTANT SPASTICITY HAD X-RAY-DOCUMENTED PUMP-CATHETER CONNECTOR DEFECT.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | INTRATHECAL CATHETER | LKK | MEDTRONIC NEUROMODULATION | UNK | UNK |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Required Intervention | IMPLANTABLE INFUSION PUMP MODEL UNK| PROGRAMMER MODEL UNK |