FDA Adverse Event
Malfunction
Summary report: N
SYNERGY
MDR report key: 1831854
·
Received September 8, 2010
Report
- Report Number
- 3004209178-2010-06872
- Event Type
- Malfunction
- Date Received
- September 8, 2010
- Report Date
- August 11, 2010
- Manufacturer
- MDT PUERTO RICO OPERATIONS CO., JUNCOS
- Product Code
- LGW
- PMA / PMN Number
- P840001
- Adverse Event
- Yes
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- IN, US
- Reporter Occupation
- PHYSICIAN ASSISTANT
Narratives
Additional Manufacturer Narrative · 1
(B)(4).
Description of Event or Problem · 1
IT WAS REPORTED THAT THE PATIENT FELT A SHOCKING OR JOLTING SENSATION DOWN THE RIGHT ARM WHEN THE STIMULATION WAS TURNED ON. NO FURTHER DETAILS, PATIENT SYMPTOMS OR OUTCOME WERE PROVIDED. ADDITIONAL INFORMATION WAS REQUESTED BUT NOT RECEIVED AT THE TIME OF THIS REPORT. A FOLLOW-UP REPORT WILL BE FILED IF ADDITIONAL INFORMATION BECOMES AVAILABLE.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | SYNERGY | LGW | MDT PUERTO RICO OPERATIONS CO., JUNCOS | 7427 | NA |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | IMPLANTED:| LEAD: MODEL 3487A, LOT# J0421749V| IMPLANTED:| LEAD: MODEL 3487A, LOT# J0454748V| EXTENSION: MODEL 7489, LOT# NHU041786V| EXTENSION: MODEL 7489, LOT# NHU057373V| PROGRAMMER: MODEL 7435, LOT# NFT045663P| EXPLANTED:| IMPLANTED:| EXPLANTED:| IMPLANTED:| EXPLANTED:| EXPLANTED:| EXPLANTED:| IMPLANTED: |