FDA Adverse Event
Malfunction
Summary report: N
SYNCHROMED II
MDR report key: 2831590
·
Received November 14, 2012
Report
- Report Number
- 3004209178-2012-10242
- Event Type
- Malfunction
- Date Received
- November 14, 2012
- Date of Event
- October 20, 2012
- Report Date
- October 20, 2012
- Manufacturer
- MDT PUERTO RICO OPERATIONS CO
- Product Code
- LKK
- PMA / PMN Number
- P860004
- Adverse Event
- Yes
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- NC, US
- Reporter Occupation
- PHYSICIAN
Narratives
Additional Manufacturer Narrative · 1
(B)(4).
Additional Manufacturer Narrative · 1
CATHETER MODEL: 8709, SERIAL# (B)(4), IMPLANTED: (B)(6) 2005, EXPLANTED: UNK. (B)(4).
Additional Manufacturer Narrative · 1
CATHETER MODEL: 8709, SERIAL# (B)(4), IMPLANTED: (B)(6) 2005, EXPLANTED: UNK. (B)(4).
Description of Event or Problem · 1
IT WAS REPORTED THAT PATIENT HAD EXPERIENCED WITHDRAWAL; HAD "WITHDRAWAL SYMPTOMS" FOR 16 HRS SINCE MID-NIGHT OF (B)(6) 2012. THE PUMP WAS REFILLED AS OF THE DATE OF THIS REPORT AND THEY ASPIRATED 4ML AND HAD EXPECTED 3.4ML, WHICH WAS WITHIN NORMAL LIMITS. IT WAS STATED THAT THE PATIENT WAS BEING SUPPORTED WITH ORAL MEDICATION AND THEY WERE CONTEMPLATING A CATHETER DYE STUDY. THE DRUGS DELIVERED VIA THE DEVICE WERE FENTANYL AND BUPIVACAINE. ADDITIONAL INFORMATION HAS BEEN REQUESTED, BUT WAS NOT AVAILABLE AS OF THE DATE OF THIS REPORT.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | SYNCHROMED II | PUMP, INFUSION, IMPLANTED, PROGRAMMABLE | LKK | MDT PUERTO RICO OPERATIONS CO | 863720 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 60 YR | Other |