FDA Adverse Event
Death
Summary report: N
SYNCHROMED II
MDR report key: 2071775
·
Received April 21, 2011
Report
- Report Number
- 3004209178-2011-02973
- Event Type
- Death
- Date Received
- April 21, 2011
- Date of Event
- March 29, 2011
- Report Date
- April 7, 2011
- Manufacturer
- MDT PUERTO RICO OPERATIONS CO., JUNCOS
- Product Code
- LKK
- PMA / PMN Number
- P860004
- Adverse Event
- Yes
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- WI, US
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
(B)(4). THE PUMP HAS BEEN RETURNED TO THE MANUFACTURER FOR ANALYSIS. A FOLLOW-UP REPORT WILL BE SENT WHEN THE ANALYSIS IS COMPLETE.
Description of Event or Problem · 1
IT WAS REPORTED THAT THE PATIENT HAD HIS DEVICE EXPLANTED AND THEN DIED THE SAME DAY. THE CAUSE OF DEATH WAS UNKNOWN AND PENDING AUTOPSY RESULTS. THE MEDICATION BEING DELIVERED VIA THE DEVICE SYSTEM WAS NOT REPORTED. ADDITIONAL INFORMATION HAS BEEN REQUESTED, A FOLLOW-UP REPORT WILL BE SENT IF ADDITIONAL INFORMATION BECOMES AVAILABLE.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | SYNCHROMED II | LKK | MDT PUERTO RICO OPERATIONS CO., JUNCOS | 863720 | NA |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 31 YR | Death | EXPLANTED:| IMPLANTED:| EXPLANTED:| CATHETER: MODEL 8709SC, LOT# N133478030| CATHETER: MODEL 8596SC, LOT# N136380020| IMPLANTED: |