FDA Adverse Event
Injury
Summary report: N
SYNCHROMED II
MDR report key: 1101843
·
Received August 7, 2008
Report
- Report Number
- 2182207-2008-04790
- Event Type
- Injury
- Date Received
- August 7, 2008
- Report Date
- July 9, 2008
- Manufacturer
- MEDTRONIC NEUROMODULATION
- Product Code
- LKK
- PMA / PMN Number
- P860004
- Removal / Correction Number
- PENDING
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- US
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
THE SYNCHROMED II PUMP SERIAL NUMBER IS WITHIN THE SUSPECTED POPULATION OF INFUSION. DEVICE THAT ARE POTENTIALLY MISSING PROPELLANT AS DESCRIBED IN MEDTRONIC'S PHYSICIAN LETTER DATED MAY 2008. (SYNCHROMED II MISSING PROPELLANT RECALL, DATED MAY 2008, Z# PENDING).
Description of Event or Problem · 1
IT WAS REPORTED THAT THE PT EXPERIENCED WEAKNESS AND HAS FALLEN ON MORE THAN ONE OCCASION. THE HCP PLANNED TO PERFORM AN MRI TO CHECK FOR INFLAMMATORY MASS. ADDITIONAL INFO HAS BEEN REQUESTED FROM THE HCP, 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 | LKK | MEDTRONIC NEUROMODULATION | 8637 | NA |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Required Intervention | CATHETER MODEL 8709 LOT# N089643032| IMPLANTED:| PROGRAMMER MODEL 8840 LOT# UNK| EXPLANTED: |