FDA Adverse Event
Injury
Summary report: N
SYNCHROMED II
MDR report key: 2914371
·
Received January 14, 2013
Report
- Report Number
- 3004209178-2013-00565
- Event Type
- Injury
- Date Received
- January 14, 2013
- Report Date
- December 20, 2012
- Manufacturer
- MDT PUERTO RICO OPERATIONS CO
- Product Code
- LKK
- PMA / PMN Number
- P860004
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- MN, US
- Reporter Occupation
- PHYSICIAN
Narratives
Additional Manufacturer Narrative · 1
PRODUCT ID 8835, SERIAL # (B)(4), PRODUCT TYPE PROGRAMMER; PATIENT PRODUCT ID (B)(4), SERIAL # (B)(4), IMPLANTED: (B)(6) 2012, PRODUCT TYPE CATHETER. (B)(4).
Description of Event or Problem · 1
IT WAS REPORTED THAT UPON EXAMINATION/PALPATION, IT WAS NOTED THERE WAS PARTIAL WOUND DEHISCENCE. THE PATIENT EXPERIENCED SLIGHT SUPERFICIAL DEHISCENCE OF THE SKIN EDGES IN ONE PART OF THE PUMP POCKET WOUND. RECLOSURE OF SURGICAL INCISION WAS DONE ON (B)(6) 2012. THE SEVERITY WAS MILD. THE OUTCOME WAS RESOLVED WITHOUT SEQUELAE. THE PUMP WAS DELIVERING FENTANYL AND BUPIVACAINE.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 20649 | SYNCHROMED II | PUMP, INFUSION, IMPLANTED, PROGRAMMABLE | LKK | MDT PUERTO RICO OPERATIONS CO | 8637-20 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 00044 YR | Required Intervention |