FDA Adverse Event
Malfunction
Summary report: N
SYNCHROMED II
MDR report key: 2823284
·
Received November 7, 2012
Report
- Report Number
- 3004209178-2012-10015
- Event Type
- Malfunction
- Date Received
- November 7, 2012
- Date of Event
- October 11, 2012
- Report Date
- October 11, 2012
- Manufacturer
- MDT PUERTO RICO OPERATIONS CO
- Product Code
- LKK
- PMA / PMN Number
- P860004
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- UK
- Reporter Occupation
- PHYSICIAN
Narratives
Additional Manufacturer Narrative · 1
(B)(4).
Additional Manufacturer Narrative · 1
(B)(4).
Description of Event or Problem · 1
IT WAS REPORTED THAT THE PATIENT HAD AN MRI AND FOLLOWING THE MRI A FALSE MOTOR STALL OCCURRED. ON (B)(6) 2012 THE PATIENT HAD AN MRI AND UPON INTERROGATION OF THE PUMP, THE PUMP LOGGED THAT A MOTOR STALL HAD OCCURRED, WITH NO RECOVERY. THE PUMP WAS THEN IMMEDIATELY INTERROGATED AGAIN, AND THE MOTOR STALL WAS THEN LOGGED AT THE SAME TIME AS THE FIRST INTERROGATION, WHICH CONFIRMED THE FALSE MOTOR STALL. THERE WERE NO PATIENT SYMPTOMS RELATED TO THE EVENT. IT WAS LATER REPORTED THAT AS OF (B)(6) 2012, THE PUMP WAS STILL WORKING AS EXPECTED AND THE PATIENT WAS WELL AND RECEIVING THERAPY. THE PUMP MEDICATIONS WERE HYDROMORPHONE AND CLONIDINE. 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 | PUMP, INFUSION, IMPLANTED, PROGRAMMABLE | LKK | MDT PUERTO RICO OPERATIONS CO | 8637-40 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |