FDA Adverse Event
Malfunction
Summary report: N
SYNCHROMED II
MDR report key: 3122852
·
Received May 21, 2013
Report
- Report Number
- 3004209178-2013-08002
- Event Type
- Malfunction
- Date Received
- May 21, 2013
- Report Date
- April 25, 2013
- Manufacturer
- MDT PUERTO RICO OPERATIONS CO
- Product Code
- LKK
- PMA / PMN Number
- P860004
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- MN, US
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
(B)(4).
Additional Manufacturer Narrative · 1
ANALYSIS OF THE PUMP REVEALED NO ANOMALIES.
Additional Manufacturer Narrative · 1
IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.
Description of Event or Problem · 1
IT WAS REPORTED THAT A PUMP INTERROGATION INDICATED A PUMP WAS IN SHELF STATE. THE PUMP WAS NOT IMPLANTED AND WAS STILL IN THE BOX. THE PUMP HAD A PENDING ALARM. THIS WAS NOTED THE DAY PRIOR TO THE REPORT AT AN IMPLANT PROCEDURE. THE LOGS REVEALED A MOTOR STALL OCCURRED ON (B)(6) 2012 AT 11:28 AND A RECOVERY OCCURRED ON THE SAME DAY AT 18:55. ANOTHER STALL OCCURRED ON (B)(6) 2012 AT 9:42 WITH A RECOVERY AT 13:48. THE PUMP WAS NOTED TO HAVE BEEN PART OF THE REPRESENTATIVE¿S TRUNK STOCK.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 224291 | SYNCHROMED II | PUMP, INFUSION, IMPLANTED, PROGRAMMABLE | LKK | MDT PUERTO RICO OPERATIONS CO | 863740 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |