FDA Adverse Event
Injury
Summary report: N
SYNCHROMED II
MDR report key: 1940373
·
Received December 20, 2010
Report
- Report Number
- 3004209178-2010-10616
- Event Type
- Injury
- Date Received
- December 20, 2010
- Date of Event
- December 3, 2010
- Report Date
- December 6, 2010
- 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
- AR, US
- Reporter Occupation
- NOT APPLICABLE
Narratives
Additional Manufacturer Narrative · 1
(B)(4).
Description of Event or Problem · 1
THE PT HAD A CATHETER REPLACEMENT PROCEDURE ON (B)(6) 2010 AFTER WHICH SHE EXPERIENCED PAIN DUE TO THE "PUMP NOT BEING TURNED UP" AFTER THE CATHETER WAS REPLACED. THE REASON FOR THE CATHETER REPLACEMENT WAS NOT STATED. THE MEDICATION BEING DELIVERED VIA THE DEVICE SYSTEM WAS NOT REPORTED. ADDITIONAL INFO HAS BEEN REQUESTED, A FOLLOW-UP REPORT WILL BE SENT IF ADDITIONAL INFO BECOMES AVAILABLE.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | SYNCHROMED II | LKK | MDT PUERTO RICO OPERATIONS CO., JUNCOS | 8637-40 | NA |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 46 YR | Required Intervention | EXPLANTED:| IMPLANTED:| CATHETER: MODEL 8709, LOT #: J11401R52 |