FDA Adverse Event
Injury
Summary report: N
SYNCHROMED EL
MDR report key: 3123756
·
Received May 22, 2013
Report
- Report Number
- 6000030-2013-00118
- Event Type
- Injury
- Date Received
- May 22, 2013
- Report Date
- May 1, 2013
- Manufacturer
- RICE CREEK MFG
- Product Code
- LKK
- PMA / PMN Number
- P860004
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- TN, US
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
PRODUCT ID 8709, LOT # L73869, IMPLANTED: (B)(6) 2000, PRODUCT TYPE CATHETER. (B)(4).
Description of Event or Problem · 1
IT WAS REPORTED THAT ABOUT A WEEK AFTER IMPLANT, THE PATIENT HAD A STROKE. THE PATIENT WAS TOLD THAT IT WAS CAUSED BY THE SHOCK TO HER BODY FROM HAVING THE PUMP IMPLANTED. ADDITIONAL INFORMATION HAS BEEN REQUESTED; A FOLLOW-UP REPORT WILL BE SENT IF INFORMATION BECOMES AVAILABLE.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 226143 | SYNCHROMED EL | PUMP, INFUSION, IMPLANTED, PROGRAMMABLE | LKK | RICE CREEK MFG | 8627-18 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 00048 YR | Other |