FDA Adverse Event
Injury
Summary report: N
SYNCHROMED II
MDR report key: 3012486
·
Received March 20, 2013
Report
- Report Number
- 3004209178-2013-03954
- Event Type
- Injury
- Date Received
- March 20, 2013
- Report Date
- February 20, 2013
- 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
- GA, US
- Reporter Occupation
- PHYSICIAN
Narratives
Additional Manufacturer Narrative · 1
CATHETER: MODEL 8709SC, SERIAL# (B)(4), IMPLANTED: 2012 (B)(6), EXPLANTED: UNK. (B)(4).
Description of Event or Problem · 1
THE DEVICE WAS EXPLANTED DUE TO A SUSPECTED TITANIUM ALLERGY. THEY TESTED WITH A KIT AND THE PATIENT WAS ALLERGIC, CULTURE OF AREA CAME BACK NEGATIVE. THE PUMP POCKET INCISION "JUST WOULD NOT HEAL," THE PUMP WAS ERODING, THE WOUND BEGAN TO DEHISCE, "IT WAS PRACTICALLY COMING ALL THE WAY OUT." THE PATIENT HAD "WEIRD," RED, SPLOTCHY RASHES, THE POCKET TISSUE WAS RED AN IRRITATED. THE DEVICE WAS DISCARDED, NOT TO BE RETURNED. THE PATIENT OUTCOME WAS NOTED AS "DOING FINE," THERE WERE NO LASTING INJURIES, AND WAS MANAGED WITH ORAL PAIN MEDS. THE DEVICE SYSTEM WAS USED TO INFUSE FENTANYL AND THEN SALINE.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 116400 | SYNCHROMED II | PUMP, INFUSION, IMPLANTED, PROGRAMMABLE | LKK | MDT PUERTO RICO OPERATIONS CO | 8637-40 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Required Intervention |