SYNCHROMED II
Report
- Report Number
- 3004209178-2013-07930
- Event Type
- Injury
- Date Received
- May 20, 2013
- Report Date
- April 22, 2013
- Manufacturer
- MDT PUERTO RICO OPERATIONS CO
- Product Code
- LKK
- PMA / PMN Number
- P860004
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- OH, US
- Reporter Occupation
- OTHER
Narratives
(B)(4).
IT WAS REPORTED THE PATIENT HAD HER DEVICE EXPLANTED AFTER JUST FOUR WEEKS OF RECEIVING IT. REPORTEDLY, THE MEDICINE ¿NEVER¿ HELPED THE PATIENT AND AS A RESULT, SHE HAD TO PUT HERSELF INTO HOSPICE FOR PAIN RELIEF. THE PATIENT STATED THE FIRST WEEK SHE HAD THE PUMP, SHE ¿BLACKED OUT.¿ THE PATIENT WAS REPORTEDLY GIVEN ATIVAN FOR THIS. IT WAS SAID THE PATIENT NEVER HAD THERAPEUTIC EFFECT. THE PATIENT REPORTED ¿EXTREME PAIN¿ FROM THE PUMP ¿BEING INSIDE OF HER.¿ THESE SYMPTOMS BEGAN FOLLOWING THE IMPLANT. THE LOCATION OF THE PAIN WAS DESCRIBED ¿OVER THE ENTIRE SYSTEM¿. THE PATIENT STATED SHE WEIGHED (B)(6) AND THE PUMP WAS ¿KILLING HER.¿ THE PATIENT SAID SHE ALL SHE COULD DO WAS ¿LAY ON THE BED AND CRY,¿ AND THAT SHE ¿CRIED FOR TWO WEEKS STRAIGHT.¿ THE PATIENT STATED THE FRONT OF THE PUMP MADE IT FEEL AS HER RIBS WERE GOING TO BREAK. REPORTEDLY, THE PATIENT WAS UNABLE TO EAT, SLEEP, WALK OR BEND OVER DUE TO THIS PAIN. THE PATIENT STATED THE PUMP WAS ¿ON HER SPINE,¿ AND SHE HAD CANCER IN SPINE, SCOLIOSIS AND ARTHRITIS. DESPITE MEDICATION DOSE INCREASES, HER PAIN CONTROL WAS NOT ANY BETTER. THE PATIENT ELECTED TO HAVE THE DEVICE REMOVED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 222651 | SYNCHROMED II | PUMP, INFUSION, IMPLANTED, PROGRAMMABLE | LKK | MDT PUERTO RICO OPERATIONS CO | 8637-20 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 00059 YR | Required Intervention |