FDA Adverse Event
Malfunction
Summary report: N
SYNCHROMED II
MDR report key: 1950367
·
Received December 14, 2010
Report
- Report Number
- 3007566237-2010-10479
- Event Type
- Malfunction
- Date Received
- December 14, 2010
- Date of Event
- December 1, 2010
- Report Date
- December 3, 2010
- Manufacturer
- MEDTRONIC NEUROMODULATION
- Product Code
- LKK
- PMA / PMN Number
- P860004
- Adverse Event
- Yes
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- CA, US
- Reporter Occupation
- PHYSICIAN
Narratives
Additional Manufacturer Narrative · 1
(B)(4).
Description of Event or Problem · 1
IT WAS REPORTED THAT THE PT HEARD THEIR PUMP ALARM EVERY HOUR. THE PT DID NOT HAVE ANY SYMPTOMS PRESENT. THE PHYSICIAN CONFIRMED A MOTOR STALL WITH NO RECOVERY ON (B)(6) 2010. THE PT WAS AT PHYSICAL THERAPY AT THE TIME OF THE STALL. A TUBE SET ERROR MESSAGE OCCURRED ON (B)(6) 2010 AT 1449. THE MEDICATIONS BEING DELIVERED VIA THE DEVICE SYSTEM WERE CLONIDINE AND BACLOFEN. ADDITIONAL INFORMATION HAS BEEN REQUESTED, A FOLLOW-UP REPORT WILL BE SENT IF ADDITIONAL INFORMATION BECOMES AVAILABLE.
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 | 66 YR | EXPLANTED:| CATHETER: MODEL 8709, LOT# N00127015| IMPLANTED: |