FDA Adverse Event
Malfunction
Summary report: N
SYNCHROMED II
MDR report key: 1031334
·
Received April 18, 2008
Report
- Report Number
- 2182207-2008-02063
- Event Type
- Malfunction
- Date Received
- April 18, 2008
- Date of Event
- March 1, 2008
- Report Date
- March 21, 2008
- 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
Description of Event or Problem · 1
IT WAS REPORTED THAT THE PT EXPERIENCED WITHDRAWAL SYMPTOMS INCLUDING LOSS OF THERAPEUTIC EFFECT BEGINNING APPROX A WEEK BEFORE THE REPORT. THE PT ALSO REPORTED HEARING THE PUMP ALARM BEGINNING AT THE SAME TIME. TELEMETRY CONFIRMED A CRITICAL ALARM WAS SOUNDING DUE TO A MOTOR STALL. THE PT WAS BEING SUPPLEMENTED WITH ORAL MORPHINE. NO PT OUTCOME WAS REPORTED. ADD'L INFO HAS BEEN REQUESTED FROM THE HCP, BUT WAS NOT AVAIL AS OF THE DATE OF THIS REPORT. A F/U REPORT WILL BE SENT IF ADD'L INFO IS RECEIVED.
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 | PROGRAMMER MODEL 8840 LOT# UNK| CATHETER MODEL 8709 LOT# J11618R30 IMPLANTED |