FDA Adverse Event
Malfunction
Summary report: N
SYNCHROMED II
MDR report key: 2191792
·
Received July 22, 2011
Report
- Report Number
- 3004209178-2011-05712
- Event Type
- Malfunction
- Date Received
- July 22, 2011
- Date of Event
- June 26, 2011
- Report Date
- July 5, 2011
- Manufacturer
- MEDTRONIC PUERTO RICO OPERATIONS CO., JUNCOS
- Product Code
- LKK
- PMA / PMN Number
- P860004
- 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'S PUMP HAD MOTOR STALL, THE STALL WAS CONFIRMED IN THE EVENT LOGS. NO RECOVERY WAS NOTED. THE STALL OCCURRED ON (B)(6) AT 8:30 AM, THE PT WAS NOT NEAR ANY EMI AND HAD NOT HAD AN MRI. THE PUMP WAS IN STALL MODE AND THE PT WAS NOT RECEIVING MEDICATION. THE PUMP WAS SCHEDULED TO BE REPLACED. THE PT HAD AN INCREASE IN PAIN. THE DRUGS USED IN THE PUMP AT THE TIME OF THE EVENT WERE HYDROMORPHONE, CLONIDINE, AND BUPIVICAINE. ADD'L INFO HAS BEEN REQUESTED; A FOLLOW-UP REPORT WILL BE SUBMITTED IF ADD'L INFO BECOMES AVAILABLE.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | SYNCHROMED II | LKK | MEDTRONIC PUERTO RICO OPERATIONS CO., JUNCOS | 863740 | NA |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 56 YR | CATHETER: MODEL 8578, LOT # N126777| IMPLANTED:| IMPLANTED:| EXPLANTED:| EXPLANTED:| ACCESSORY: MODEL 8590-1, LOT# N117632| EXPLANTED:| CATHETER: MODEL 8709, LOT # N120318009| IMPLANTED: |