FDA Adverse Event
Injury
Summary report: N
SYNCHROMED II
MDR report key: 3133286
·
Received May 29, 2013
Report
- Report Number
- 3004209178-2013-08238
- Event Type
- Injury
- Date Received
- May 29, 2013
- Report Date
- May 6, 2013
- Manufacturer
- MDT PUERTO RICO OPERATIONS CO
- Product Code
- LKK
- PMA / PMN Number
- P860004
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- UK
- Reporter Occupation
- HEALTH PROFESSIONAL
Narratives
Additional Manufacturer Narrative · 1
(B)(4).
Additional Manufacturer Narrative · 1
(B)(4).
Description of Event or Problem · 1
ADDITIONAL INFORMATION: PRIOR TO EXPLANT THE PATIENT WAS HAVING SPASMS AND NOT SLEEPING. THERE WERE NO WOUND CONCERNS OR WOUND BREAKDOWN. FOLLOWING EXPLANT, THE PATIENT WAS BEING MANAGED ON ORAL BACLOFEN. THE PUMP WAS DELIVERING LIORESAL.
Description of Event or Problem · 1
THE WOUND BECAME INFECTED FOLLOWING IMPLANT. THE PUMP WAS REMOVED. THE PUMP WAS DELIVERING BACLOFEN.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 236662 | SYNCHROMED II | PUMP, INFUSION, IMPLANTED, PROGRAMMABLE | LKK | MDT PUERTO RICO OPERATIONS CO | 8637-20 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Required Intervention |