FDA Adverse Event
Malfunction
Summary report: N
SYNCHROMED II
MDR report key: 2172352
·
Received June 23, 2011
Report
- Report Number
- 3007566237-2011-04740
- Event Type
- Malfunction
- Date Received
- June 23, 2011
- Date of Event
- May 1, 2011
- Report Date
- May 28, 2011
- Manufacturer
- MEDTRONIC NEUROMODULATION
- Product Code
- LKK
- PMA / PMN Number
- P860004
- Adverse Event
- Yes
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- MN, US
- Reporter Occupation
- NOT APPLICABLE
Narratives
Additional Manufacturer Narrative · 1
(B)(4).
Description of Event or Problem · 1
IT WAS REPORTED THAT THE PATIENT PRESENTED IN THE EMERGENCY ROOM WITH "SYMPTOMS OF OVERDOSE," ACCORDING TO THE EMERGENCY ROOM NURSE. THE PATIENT WAS DROWSY BUT RESPONDED APPROPRIATELY TO STIMULI. SHE COMMUNICATED THAT SHE HAD HER PUMP LAST REFILLED TWO DAYS AGO ON (B)(6) 2011. THE PUMP LOGS REVEALED NO MOTOR STALLS ON INTERROGATION. NO INFORMATION AS REGARDS TO THE DRUG, DOSAGE OR CONCENTRATION WAS AVAILABLE. ADDITIONAL INFORMATION 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 | 863720 | NA |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 62 YR | Other | EXPLANTED:| CATHERTER: MODEL 8709, LOT# J12184R13| IMPLANTED: |