FDA Adverse Event
Injury
Summary report: N
SYNCHROMED II
MDR report key: 2230557
·
Received August 12, 2011
Report
- Report Number
- 3004209178-2011-06294
- Event Type
- Injury
- Date Received
- August 12, 2011
- Date of Event
- January 1, 2011
- Report Date
- July 21, 2011
- Manufacturer
- MDT PUERTO RICO OPERATIONS CO., JUNCOS
- Product Code
- LKK
- PMA / PMN Number
- P860004
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- MN, US
- Reporter Occupation
- NOT APPLICABLE
Narratives
Additional Manufacturer Narrative · 1
(B)(4).
Description of Event or Problem · 1
IT WAS REPORTED THAT THE PT'S CATHETER WAS REVISED. THE ENTIRE SPINAL SEGMENT OF THE CATHETER HAD COME OUT OF THE INTRATHECAL SPACE AND WAS COILED UP IN THE INCISION SITE AT THE WOUND AND BUNCHED UP. THAT CATHETER WAS REMOVED AND A NEW SPINAL SEGMENT CATHETER WAS INSERTED AND CONNECTED BACK UP TO THE EXISTING PUMP-SEGMENT CATHETER. THE PUMP WAS TURNED ON AND I'M SURE THE PT WAS FINE FOLLOWING THE REVISION. THE DRUGS USED IN THE PUMP AT THE TIME OF THE EVENT WERE DILAUDID, BUPIVICAINE, AND BACLOFEN.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | SYNCHROMED II | LKK | MDT PUERTO RICO OPERATIONS CO., JUNCOS | 8637-40 | NA |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 66 YR | Required Intervention | EXPLANTED:| CATHETER: MODEL 8709SC, LOT # N291304011| CATHETER: MODEL 8596SC, LOT # N256689014| IMPLANTED:| EXPLANTED:| IMPLANTED: |