FDA Adverse Event
Injury
Summary report: N
SYNCHROMED II
MDR report key: 1892241
·
Received November 2, 2010
Report
- Report Number
- 3004209178-2010-08764
- Event Type
- Injury
- Date Received
- November 2, 2010
- Date of Event
- June 1, 2010
- Report Date
- October 8, 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
- MN, US
- Reporter Occupation
- NOT APPLICABLE
- Health Professional
- N
Narratives
Additional Manufacturer Narrative · 1
(B)(4).
Description of Event or Problem · 1
IT WAS REPORTED A MOTOR STALL OCCURRED. CONFIRMED MOTOR STALL AND MOTOR STALL RECOVERY RECORDED IN EVENT LOGS. THE MOTOR STALLS HAPPENED IN (B)(6) AND (B)(6). ONE RECOVERED AFTER 20 MIN AND THE OTHER AFTER 2 HRS. THE PT DID NOT HAVE A MAGNETIC RESONANCE IMAGING (MRI). THE PT HAD NO STALLS SINCE THEN. THE PT WAS HAVING POCKET REVISION TODAY. AT THE TIME OF THIS REPORT, NO FURTHER DETAILS WERE REPORTED. ADD'L INFO WAS REQUESTED AND WILL BE PROVIDED WHEN IT BECOMES AVAILABLE.
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 | 52 YR | Female | Required Intervention | CATHETER: MODEL 8709, LOT# N067217017| EXPLANTED:| IMPLANTED:| IMPLANTED:| EXPLANTED:| CATHETER: MODEL 8709, LOT# N067217017 |