FDA Adverse Event
Malfunction
Summary report: N
SYNGERGY
MDR report key: 1083097
·
Received July 24, 2008
Report
- Report Number
- 3004209178-2008-04341
- Event Type
- Malfunction
- Date Received
- July 24, 2008
- Date of Event
- June 1, 2008
- Report Date
- June 24, 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
- US
- Reporter Occupation
- NURSE
Narratives
Description of Event or Problem · 1
IT WAS REPORTED IMPEDANCES >4000 OHMS WITH 0-3 AND <15UA. THE PATIENT ALSO EXPERIENCED A LOSS OF THERAPEUTIC EFFECT. THE HCP ATTEMPTED TO REPROGRAM WITH 4-7 FOR TEMPORARY PAIN RELIEF. NO OUTCOME WAS REPORTED. ADDITIONAL INFORMATION HAS BEEN REQUESTED, A FOLLOW-UP REPORT WILL BE SUBMITTED IF ADDITIONAL INFORMATION BECOMES AVAILABLE.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | SYNGERGY | LGW | MEDTRONIC PUERTO RICO OPERATIONS CO. | 7427 | NA |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Required Intervention | EXTENSION MODEL 7489 LOT# NHU085668V| IMPLANTED:| EXPLANTED:| LEAD MODEL 3998 LOT# V013489| IMPLANTED:| EXTENSION MODEL 7489 LOT# NHU120042V| EXPLANTED:| IMPLANTED:| EXPLANTED: |