FDA Adverse Event
Injury
Summary report: N
SYNCHROMED II
MDR report key: 1770238
·
Received July 21, 2010
Report
- Report Number
- 3004209178-2010-05666
- Event Type
- Injury
- Date Received
- July 21, 2010
- Date of Event
- June 21, 2010
- Report Date
- June 23, 2010
- Manufacturer
- MDT PUERTO RICO OPERATIONS CO., JUNCOS
- Product Code
- LKK
- PMA / PMN Number
- P860004
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- IL, US
- Reporter Occupation
- PHYSICIAN
Narratives
Additional Manufacturer Narrative · 1
(B)(4).
Description of Event or Problem · 1
IT WAS REPORTED THAT THE PT PRESENTED TO THE EMERGENCY ROOM. THE "PAIN DOCTOR" WAS CONTACTED AND HE TOOK THE PT TO THE OPERATING ROOM AND REMOVED THE ENTIRE DEVICE SYSTEM. PER THE REPORTER, ALL COMPONENTS WERE THROWN OUT. THE PHYSICIAN INDICATED THAT THE REASON FOR REMOVAL WAS "INFECTION AND SUTURE HOLDING PUMP INFECTED". THE PT WAS ON ORAL PRESCRIPTION AND HAD NO FURTHER COMPLICATIONS. THE TYPE OF MEDICATION, CONCENTRATION, AND DAILY DOSE BEING ADMINISTERED VIA THE PUMP WERE NOT REPORTED. ADDITIONAL INFO HAS BEEN REQUESTED, A FOLLOW-UP REPORT WILL BE SENT IF ADDITIONAL INFO BECOMES AVAILABLE.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | SYNCHROMED II | LKK | MDT PUERTO RICO OPERATIONS CO., JUNCOS | 8637-40 | NA |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 68 YR | Required Intervention | CATHETER: MODEL 8709, LOT# L64778| IMPLANTED:| EXPLANTED: |