FDA Adverse Event
Malfunction
Summary report: N
SYNCHROMED II
MDR report key: 2152317
·
Received June 23, 2011
Report
- Report Number
- 3007566237-2011-04709
- Event Type
- Malfunction
- Date Received
- June 23, 2011
- Date of Event
- May 26, 2011
- Report Date
- May 27, 2011
- Manufacturer
- MEDTRONIC NEUROMODULATION
- Product Code
- LKK
- PMA / PMN Number
- P860004
- Adverse Event
- Yes
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- US
- Reporter Occupation
- PHYSICIAN
Narratives
Additional Manufacturer Narrative · 1
(B)(4).
Description of Event or Problem · 1
IT WAS REPORTED THAT THE PATIENT HEARD AN ALARM AND STATED THAT HE WAS NOT RECEIVING ANY MEDICATION. THE TELEMETRY DID NOT SHOW AN ALARM. UNDERDOSE WAS REPORTED AND PATIENT WAS TAKEN TO THE EMERGENCY ROOM. THE DRUG INFUSED VIA THE PUMP WAS DILAUDID (DOSE/CONC. UNKNOWN). SEVERAL ATTEMPTS TO FOLLOW-UP WITH THE HCP FOR ADDITIONAL INFORMATION WERE MADE WITHOUT SUCCESS.
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 | UNK |