FDA Adverse Event
Injury
Summary report: N
SYNCHROMED
MDR report key: 1800019
·
Received August 12, 2010
Report
- Report Number
- 3007566237-2010-06066
- Event Type
- Injury
- Date Received
- August 12, 2010
- Date of Event
- June 11, 2010
- Report Date
- March 28, 2017
- Manufacturer
- MEDTRONIC NEUROMODULATION
- Product Code
- LKK
- PMA / PMN Number
- P860004
- Removal / Correction Number
- Z-1570-2014
- Adverse Event
- Yes
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- MN, US
- Reporter Occupation
- NOT APPLICABLE
- Health Professional
- N
Narratives
Additional Manufacturer Narrative · 1
(B)(4)
Description of Event or Problem · 1
IT WAS REPORTED THE PT'S PUMP OVERDOSED. PHYSICIAN SUSPECTED PUMP RAN TOO FAST AND WAS NOT WITHIN RANGE, SO PHYSICIAN CONFIRMED A TRIAL AND USED SALINE. PT WAS FINE. DRUG USED, DOSAGE AND CONCENTRATION WERE UNK. ADDITIONAL INFO HAS BEEN REQUESTED AND WILL BE MADE AS FOLLOW UP AS IT BECOMES AVAILABLE.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | SYNCHROMED | LKK | MEDTRONIC NEUROMODULATION | PUMP | NA |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 68 YR | Female | Required Intervention |