FDA Adverse Event
Injury
Summary report: N
SYNCHROMED II
MDR report key: 1261610
·
Received December 11, 2008
Report
- Report Number
- 2182207-2008-08212
- Event Type
- Injury
- Date Received
- December 11, 2008
- Date of Event
- October 1, 2008
- Report Date
- November 14, 2008
- Manufacturer
- MEDTRONIC NEUROMODULATION
- Product Code
- LKK
- PMA / PMN Number
- P860004
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- VA, US
- Reporter Occupation
- NOT APPLICABLE
Narratives
Description of Event or Problem · 1
IT WAS REPORTED THAT THE PATIENT HAD AN MRI (MAGNETIC RESONANCE IMAGING) APPROXIMATELY 3 WEEKS AGO. THE REPORT INDICATED THAT THE PATIENT WAS SEEN BY THE HCP (HEALTH CARE PROFESSIONAL) THE FOLLOWING DAY FOR A PUMP REFILL AND THE 'PUMP HAD RESTARTED'. SINCE THAT TIME THE PATIENT HAS HAD A MARKED INCREASE IN PAIN. THE PATIENT WAS ADMITTED TO THE HOSPITAL. THE REPORT ALSO INDICATED THAT THE PATIENT RECENTLY UNDERWENT CHEMOTHERAPY. THE TYPE OF MEDICATION, CONCENTRATION, AND DAILY DOSE BEING ADMINISTERED VIA THE PUMP WERE NOT REPORTED. ADDITIONAL INFO HAS BEEN REQUESTED FROM THE HCP, 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 | MEDTRONIC NEUROMODULATION | 863720 | NA |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 66 YR | Hospitalization| R | IMPLANTED:| EXPLANTED:| EXPLANTED:| IMPLANTED:| CATHETER: MODEL 8575| CATHETER: MODEL 8709| PROGRAMMER: MODEL 8840 |