FDA Adverse Event
Injury
Summary report: N
SYNCHROMED II
MDR report key: 2070142
·
Received April 21, 2011
Report
- Report Number
- 3007566237-2011-02991
- Event Type
- Injury
- Date Received
- April 21, 2011
- Date of Event
- October 29, 2009
- Report Date
- April 4, 2011
- Manufacturer
- MEDTRONIC NEUROMODULATION
- Product Code
- LKK
- PMA / PMN Number
- P860004
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- LA, US
- Reporter Occupation
- PHYSICIAN
Narratives
Additional Manufacturer Narrative · 1
(B)(4).
Description of Event or Problem · 1
THE PT'S BODY REJECTED THE PUMP. THE LATEST PUMP WAS REPLACED (B)(6) 2009. THE REPLACEMENT PROCEDURE CHARTING DID NOT HAVE ADDITIONAL INFO REGARDING THE EXPLANTED DEVICE. THERE WAS ALSO NO INFO NOTED ON PT SIGNS OR SYMPTOMS OR ANY TESTING DONE PRIOR TO REPLACEMENT. A FOLLOW-UP REPORT WILL BE SUBMITTED IF ADDITIONAL INFO BECOMES AVAILABLE.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | SYNCHROMED II | LKK | MEDTRONIC NEUROMODULATION | 863740 | NA |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 47 YR | Required Intervention | EXPLANTED:| IMPLANTED:| IMPLANTABLE INFUSION PUMP: MODEL 863740| IMPLANTED:| IMPLANTABLE INFUSION PUMP: MODEL 8637-40,| LOT# NGV428184H| EXPLANTED:| CATHETER: MODEL 8709, LOT# J13105R19| EXPLANTED:| IMPLANTED:| LOT# NGV017200N |