FDA Adverse Event
Malfunction
Summary report: N
SYNERGY PLUS+
MDR report key: 1061804
·
Received June 13, 2008
Report
- Report Number
- 3004209178-2008-03232
- Event Type
- Malfunction
- Date Received
- June 13, 2008
- Report Date
- May 16, 2008
- Manufacturer
- MEDTRONIC PUERTO RICO OPERATIONS CO.
- Product Code
- LGW
- PMA / PMN Number
- P840001
- Adverse Event
- Yes
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- PA, US
- Reporter Occupation
- OTHER
Narratives
Description of Event or Problem · 1
IT WAS REPORTED THE PATIENT EXPERIENCED A SHOCKING OR JOLTING SENSATION DOWN THE LEG AFTER EXPOSURE TO A SECURITY GATE AT KMART. MOVEMENT AND PALPATION CAUSED STIMULATION CHANGES. AT THE TIME OF THE REPORT THE PATIENT'S STATUS WAS FAIR. THE PATIENT WAS REDIRECTED TO CONTACT THE HEALTH CARE PROFESSIONAL. ADDITIONAL INFORMATION HAS BEEN REQUESTED FROM THE HCP, BUT WAS NOT AVAILABLE AS OF THE DATE OF THIS REPORT.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | SYNERGY PLUS+ | LGW | MEDTRONIC PUERTO RICO OPERATIONS CO. | 7479 | NA |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Required Intervention | EXPLANTED:| EXPLANTED:| EXTENSION MODEL 7489| LEAD MODEL 3998| EXPLANTED:| EXTENSION MODEL 7489 |