FDA Adverse Event
Injury
Summary report: N
SYNCHROMED II
MDR report key: 2130542
·
Received June 14, 2011
Report
- Report Number
- 3004209178-2011-04420
- Event Type
- Injury
- Date Received
- June 14, 2011
- Date of Event
- May 1, 2011
- Report Date
- May 18, 2011
- Manufacturer
- MEDTRONIC PUERTO RICO OPERATIONS CO., JUNCOS
- Product Code
- LKK
- PMA / PMN Number
- P860004
- Adverse Event
- Yes
- Product Problem
- 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 THERE WERE CATHETER COMPLICATIONS. THE PATIENT'S CATHETER WAS DISLODGED. THE CATHETER ISSUE WAS CONFIRMED. A REVISION WAS RECOMMENDED. THE REPORTER SAID THAT THE CATHETER CAME OUT OF THE INTRATHECAL SPACE DISTAL TO THE ANCHOR AND "COILED UP" OUTSIDE OF THE INTRATHECAL SPACE. THE PATIENT HAD A REVISION ON "(B)(6)" AND SEEMED TO BE DOING WELL SINCE SURGERY. THE DRUG IN THE PUMP AT THE TIME OF THE EVENT WAS NOT REPORTED. ADDITIONAL INFORMATION HAS BEEN REQUESTED; A FOLLOW-UP REPORT WILL BE SUBMITTED IF ADDITIONAL INFORMATION BECOMES AVAILABLE.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | SYNCHROMED II | LKK | MEDTRONIC PUERTO RICO OPERATIONS CO., JUNCOS | 8637-40 | NA |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 30 YR | Required Intervention | IMPLANTED:| CATHETER: MODEL 8709SC, LOT# N287709009| EXPLANTED: |