FDA Adverse Event
Injury
Summary report: N
SYNCHROMED II
MDR report key: 2130537
·
Received June 14, 2011
Report
- Report Number
- 3007566237-2011-04410
- Event Type
- Injury
- Date Received
- June 14, 2011
- Date of Event
- May 13, 2011
- Report Date
- May 18, 2011
- Manufacturer
- MEDTRONIC NEUROMODULATION
- Product Code
- LKK
- PMA / PMN Number
- P860004
- Adverse Event
- Yes
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- WI, US
- Reporter Occupation
- PHYSICIAN
Narratives
Additional Manufacturer Narrative · 1
(B)(4).
Description of Event or Problem · 1
IT WAS REPORTED THAT THE PT'S PUMP WAS REPLACED ON (B)(6) 2011 DUE TO A LOSS OF THERAPEUTIC EFFECT. THE PUMP WAS RETURNED TO THE MFR AND WAS REC'D ON (B)(6) 2011. NO PT INJURY WAS REPORTED. THE PT RECOVERED W/O SEQUELAE. THE DRUG IN THE PUMP AT THE TIME OF THE EVENT WAS MORPHINE.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | SYNCHROMED II | LKK | MEDTRONIC NEUROMODULATION | 863740 | NA |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 56 YR | Required Intervention | EXPLANTED:| IMPLANTED:| CATHETER: MODEL 8709, LOT# J11998R22 |