FDA Adverse Event
Malfunction
Summary report: N
SYNCHROMED II
MDR report key: 1973640
·
Received January 18, 2011
Report
- Report Number
- 3007566237-2011-00450
- Event Type
- Malfunction
- Date Received
- January 18, 2011
- Date of Event
- December 24, 2010
- Report Date
- January 13, 2011
- Manufacturer
- MEDTRONIC NEUROMODULATION
- Product Code
- LKK
- PMA / PMN Number
- P860004
- Removal / Correction Number
- Z-2276-2009
- 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 PT EXPERIENCED FLU-LIKE SYMPTOMS STARTING BACK TO APPROX (B)(6) 2010. TELEMETRY CONFIRMED A CRITICAL ALARM ON (B)(6) 2011. THERE WERE MULTIPLE BATTERY RESET MESSAGES ON THE PUMP LOGS. AN ALARM HAS BEEN HEARD FOR ABOUT TWO WEEKS. THE PUMP WENT INTO "SAFE STATE" ON (B)(6) 2011. THEY HAD PLANNED TO PROGRAM THE PT'S PUMP TO THE MINIMUM RATE AND SUPPLEMENT THE PT WITH ORAL MEDICATIONS AS NEEDED UNTIL A PLAN FOR THE PT WAS DETERMINED. THE MEDICATIONS BEING DELIVERED VIA THE DEVICE SYSTEM WERE BUPIVICAINE, AND DILAUDID. ADDITIONAL INFO HAS BEEN REQUESTED, A FOLLOW-UP REPORT WILL BE SENT IF ADDITIONAL INFO BECOMES AVAILABLE.
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 | CATHETER: MODEL 8709, LOT # J12527R35| EXPLANTED:| IMPLANTED: |