FDA Adverse Event
Injury
Summary report: N
SYNCHROMED II
MDR report key: 1132600
·
Received August 22, 2008
Report
- Report Number
- 2182207-2008-05150
- Event Type
- Injury
- Date Received
- August 22, 2008
- Date of Event
- July 1, 2008
- Report Date
- July 22, 2008
- Manufacturer
- MEDTRONIC NEUROMODULATION
- Product Code
- LKK
- PMA / PMN Number
- P860004
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- TX, US
- Reporter Occupation
- UNKNOWN
Narratives
Additional Manufacturer Narrative · 1
PROGRAMMING INADEQUATE FOR PT NEEDS.
Description of Event or Problem · 1
THE PUMP WAS REFILLED WITH INFUMORPH 10 MG/ML AND PROGRAMMED TO DELIVER 0.5 MG/DAY. PRIOR TO REFILL IT CONTAINED NORMAL SALINE. THE NEXT DAY THE PT EXPERIENCED NAUSEA, SHORTNESS OF BREATH, AND NARCOSIS. THE PT WAS TIRED AND COULDN'T KEEP HIS EYES OPEN. THE PHYSICIAN WANTED TO LOWER THE DOSE BUT COULDN'T AT THE CURRENT DRUG CONCENTRATION. THE PHYSICIAN FELT THAT THE PUMP'S MINIMUM RATE WAS TOO SLOW FOR THE PT NEEDS. THE PUMP WAS EMPTIED OF ITS CONTENTS THE SAME DAY OF THE COMPLAINT. ADDITIONAL INFO HAS BEEN REQUESTED. 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 | 863720 | NA |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Required Intervention | EXPLANTED:| CATHETER MODEL 8709 LOT# J53426R35| PROGRAMMER MODEL 8840 LOT# UNK| IMPLANTED: |