FDA Adverse Event
Injury
Summary report: N
UNK
MDR report key: 1202827
·
Received October 17, 2008
Report
- Report Number
- 2182207-2008-06649
- Event Type
- Injury
- Date Received
- October 17, 2008
- Report Date
- September 16, 2008
- Manufacturer
- MEDTRONIC NEUROMODULATION
- Product Code
- LKK
- PMA / PMN Number
- P860004
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- OH, US
- Reporter Occupation
- PHYSICIAN
Narratives
Additional Manufacturer Narrative · 1
RESULTS = CATHETER.
Description of Event or Problem · 1
JOURNAL REFERENCE: KHERA J, GHOSH D, LUCIANO M. A STUDY OF INTRATHECAL BACLOFEN PUMPS IN CHILDREN: EXPERIENCE FROM A TERTIARY CARE CENTER. NEUROLOGY. 2008;70 (11, SUPPL.1):A131. TO DETERMINE INDICATIONS, UTILITY, AND COMPLICATIONS OF INTRATHECAL BACLOFEN (ITB) PUMP THERAPY IN CHILDREN. SINGLE CENTER, RETROSPECTIVE REVIEW AFTER IRB APPROVAL. INCLUSION CRITERIA: PTS < 21 YEARS WITH ITB PUMP PLACED BETWEEN 1996-2006. A TOTAL PTS IDENTIFIED WITH ITB FOR SPASTICITY AND DYSTONIA HAD FOLLOW-UP FOR AN AVERAGE OF 38 MOS. MFR OF PUMP AND CATHETER WAS NOT STATED. REPORTABLE EVENT: ONE PT HAD CSF LEAK. SEE MFG REPORT 2182207-2008-06629.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | UNK | LKK | MEDTRONIC NEUROMODULATION | UNK | NA |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Other | PROGRAMMER MODEL UNK N=1| CATHETER MODEL UNK N=1 |