FDA Adverse Event
Injury
Summary report: N
SYNCHROMED II
MDR report key: 1770217
·
Received July 21, 2010
Report
- Report Number
- 3004209178-2010-05643
- Event Type
- Injury
- Date Received
- July 21, 2010
- Date of Event
- July 13, 2010
- Report Date
- June 22, 2010
- Manufacturer
- MDT PUERTO RICO OPERATIONS CO., JUNCOS
- Product Code
- LKK
- PMA / PMN Number
- P860004
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- JA
- Reporter Occupation
- PHYSICIAN
Narratives
Additional Manufacturer Narrative · 1
(B)(4).
Description of Event or Problem · 1
IT WAS REPORTED THAT THE PATIENT DEVELOPED FLUID RETENTION AROUND THE PUMP POCKET APPROXIMATELY 4 DAYS AFTER IMPLANT. THE HCP ASPIRATED IT; THE FLUID RETENTION APPEARED AGAIN. IT WAS DETERMINED THAT THERE WAS A CSF (CEREBROSPINAL FLUID) LEAK. THE HCP NOTED THAT "IT DID NOT CLICK WHEN CONNECTING THE PUMP AND CATHETER AT THE OPERATION". THE HCP PLANNED TO "OPEN AND CHECK" ON (B)(6) 2010. IT WAS LATER REPORTED THAT THE PATIENT RECOVERED. THE HCP NOTED THAT "NO CATHETER OR PUMP WERE RELATED TO THIS MATTER". THE CAUSE OF THE EVENT WAS NOT REPORTED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | SYNCHROMED II | LKK | MDT PUERTO RICO OPERATIONS CO., JUNCOS | 8637-20 | NA |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 59 YR | Required Intervention | IMPLANTED:| CATHETER: MODEL 8711, LOT# N229856001| EXPLANTED: |