FDA Adverse Event
Injury
Summary report: N
SYNERGY
MDR report key: 1071632
·
Received July 9, 2008
Report
- Report Number
- 3004209178-2008-03874
- Event Type
- Injury
- Date Received
- July 9, 2008
- Date of Event
- June 1, 2008
- Report Date
- June 9, 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
- TX, US
- Reporter Occupation
- PHYSICIAN
Narratives
Description of Event or Problem · 1
THE PATIENT EXPERIENCED A SHOCKING SENSATION FROM HER LOWER BACK TO HER UPPER CHEST. IMPLANTABLE NEUROSTIMULATOR INTERROGATION SHOWED IMPEDANCES GREATER THAN 4000 OHMS ON ELECTRODES 0, 1, 2, AND 3. THE BATTERY STATUS WAS OK. THE PT WAS REFERRED TO HIS HCP FOR LEAD REVISION. ADDITIONAL INFO HAS BEEN REQUESTED, A FOLLOW-UP REPORT WILL BE SUBMITTED IF ADDITIONAL INFO BECOMES AVAILABLE.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | SYNERGY | LGW | MEDTRONIC PUERTO RICO OPERATIONS CO | 7427 | NA |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Required Intervention | IMPLANTED| IMPLANTED| EXPLANTED| IMPLANTED| PROGRAMMER MODEL 7435| EXTENSION MODEL 7489| LEAD MODEL# 399930| EXPLANTED| EXTENSION MODEL 7489| MODEL AT501| IMPLANTABLE PACEMAKER AND ACCESSORIES| EXPLANTED| IMPLANTED| EXPLANTED |