FDA Adverse Event
Injury
Summary report: N
SYNCHROMED
MDR report key: 889207
·
Received July 27, 2007
Report
- Report Number
- 2182207-2007-02453
- Event Type
- Injury
- Date Received
- July 27, 2007
- Report Date
- May 9, 2007
- Manufacturer
- MEDTRONIC NEUROMODULATION
- Product Code
- LKK
- PMA / PMN Number
- P8600004
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- VA
- Reporter Occupation
- PHYSICIAN
Narratives
Additional Manufacturer Narrative · 1
.
Description of Event or Problem · 1
THE ARTICLE LISTS INFORMATION SUGGESTING A MALE PATIENT BEING TREATED FOR SPASTICITY WITH AN IMPLANTABLE INFUSION PUMP EXPERIENCED A PUMP RELATED INFECTION 14 DAYS POST PUMP IMPLANT. THE PATIENT PRESENTED WITH AN OTHER INFECTION (UNSPECIFIED). ADDITIONAL FINDINGS DURING DEVICE EXPLANT SURGERY INCLUDED PUS AT THE POCKET SITE ALONG WITH DEHISCENCE, DRAINAGE AND ERYTHEMA. OTHER SURGICAL PROCEDURES INCLUDED DEBRIDEMENT. NO ADDITIONAL INFORMATION CONCERNING PATIENT SYMPTOMS AND OUTCOME WAS PROVIDED. JOURNAL REFERENCE: WUNDERLICH, C. ET AL. "GRAM-NEGATIVE MENINGITIS AND INFECTIONS IN INDIVIDUALS TREATED WITH INTRATHECAL BACLOFEN FOR SPASTICITY: A RETROSPECTIVE STUDY." DEVELOPMENTAL MEDICINE AND CHILD NEUROLOGY. 2006; 48: 450-455.
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 | 32 YR | Hospitalization| R | PROGRAMMER AND CATHETER |