FDA Adverse Event
Injury
Summary report: N
SYNCHROMED II
MDR report key: 2181403
·
Received July 21, 2011
Report
- Report Number
- 3004209178-2011-05652
- Event Type
- Injury
- Date Received
- July 21, 2011
- Date of Event
- June 16, 2011
- Report Date
- June 30, 2011
- Manufacturer
- MEDTRONIC PUERTO RICO OPERATIONS CO., JUNCOS
- Product Code
- LKK
- PMA / PMN Number
- P860004
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- MN, US
- Reporter Occupation
- NOT APPLICABLE
Narratives
Additional Manufacturer Narrative · 1
(B)(4).
Description of Event or Problem · 1
IT WAS REPORTED THAT THE PATIENT EXPERIENCED INCREASED BASELINE PAIN. THE SYMPTOMS BEGAN FOLLOWING A PUMP REPLACEMENT ON (B)(6) 2011. IT WAS LATER REPORTED THAT THERE WAS A CATHETER ISSUE. THE CATHETER COULD NOT BE ASPIRATED DURING A DYE STUDY. THE PATIENT WAS TAKEN TO SURGERY ON JUNE 30 AND THE ISSUE WAS APPARENTLY RESOLVED. THE DRUG USED IN THE PUMP AT THE TIME OF THE EVENT WAS MORPHINE.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | SYNCHROMED II | LKK | MEDTRONIC PUERTO RICO OPERATIONS CO., JUNCOS | 8637-20 | NA |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 56 YR | Required Intervention | LOT# NGP004245N| CATHETER: MODEL 8709, LOT# J53424R11| IMPLANTED:| IMPLANTED:| EXPLANTED:| IMPLANTABLE INFUSION PUMP: MODEL 8637-20| EXPLANTED: |