FDA Adverse Event
Malfunction
Summary report: N
SYNCHROMED II
MDR report key: 2092155
·
Received April 27, 2011
Report
- Report Number
- 3007566237-2011-03154
- Event Type
- Malfunction
- Date Received
- April 27, 2011
- Date of Event
- April 6, 2011
- Report Date
- April 11, 2011
- 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 A PATIENT HAD INCREASED LOW BACK PAIN SECONDARY TO DEVICE MALFUNCTION. DEVICE INTERROGATION ON (B)(6) 2011 REVEALED NORMAL RESULTS. A (B)(4) STUDY WITH CONTRAST WAS CONDUCTED ON (B)(6) 2011. INTERVENTION ON (B)(6) 2011 WAS NOTED AS "REPROGRAMMING/REFILL/BOLUS"; AND THE FOLLOWING PUMP MEDICATIONS WERE NOTED: 10% MORPHINE SULFATE (5.293 MG/DAY), BUPIVACAINE (1.764 MG/DAY), AND CLONIDINE (26.47 MCG/DAY). THE PATIENT'S OUTCOME WAS REPORTED AS ON-GOING. ADDITIONAL INFORMATION WILL BE PROVIDED IN A FOLLOW-UP REPORT AS IT BECOMES AVAILABLE.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | SYNCHROMED II | LKK | MEDTRONIC NEUROMODULATION | 8637-20 | NA |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 44 YR | EXPLANTED:| IMPLANTED:| CATHETER: MODEL 8711, LOT# N183904003 |