FDA Adverse Event
Injury
Summary report: N
SYNCHROMED II
MDR report key: 1960998
·
Received January 11, 2011
Report
- Report Number
- 3004209178-2011-00273
- Event Type
- Injury
- Date Received
- January 11, 2011
- Report Date
- January 4, 2011
- Manufacturer
- MDT PUERTO RICO OPERATIONS CO., JUNCOS
- Product Code
- LKK
- PMA / PMN Number
- P860004
- Adverse Event
- Yes
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- MN, US
- Reporter Occupation
- PHYSICIAN
Narratives
Additional Manufacturer Narrative · 1
(B)(4).
Description of Event or Problem · 1
FOLLOWING PUMP REPLACEMENT ON (B)(6) 2011, THE PHYSICIAN BELIEVED THE PT EXPERIENCED OVERDOSE SYMPTOMS. BECAUSE OF THIS, A "PACER-TYPE" MAGNET WAS PLACED OVER THE NEWLY IMPLANTED PUMP FOR 7-8 HOURS. ON (B)(6) 2011, A PUMP MOTOR STALL WAS NOTED IN THE EVENT LOGS WITH NO MOTOR STALL RECOVERY RECORDED. PER THE REPORTER, THE PT'S CONDITION WAS "STABLE." THE PUMP CONTAINED HYDROMORPHONE 20 MG/ML. ADD'L INFO HAS BEEN REQUESTED, BUT WAS NOT AVAILABLE AS OF THE DATE OF THIS REPORT.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | SYNCHROMED II | LKK | MDT PUERTO RICO OPERATIONS CO., JUNCOS | 863740 | NA |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Required Intervention | LOT# NGF029467R| EXPLANTED:| CATHETER: MODEL 8703W, LOT# L53272| IMPLANTED:| IMPLANTED:| IMPLANTABLE INFUSION PUMP: MODEL 8627-18,| EXPLANTED: |