FDA Adverse Event
Malfunction
Summary report: N
SYNERGY
MDR report key: 1832265
·
Received September 3, 2010
Report
- Report Number
- 3004209178-2010-06778
- Event Type
- Malfunction
- Date Received
- September 3, 2010
- Date of Event
- January 1, 2010
- Report Date
- August 9, 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
- CA, US
- Reporter Occupation
- NOT APPLICABLE
Narratives
Additional Manufacturer Narrative · 1
(B)(4).
Description of Event or Problem · 1
IT WAS REPORTED THAT THE PATIENT EXPERIENCED A SHOCKING/JOLTING SENSATION, OCCASIONALLY, FROM THE DEVICE. THE PATIENT HAD "NOT SEEN A DOCTOR IN FIVE YEARS." 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 | 71 YR | IMPLANTED:| IMPLANTED:| PROGRAMMER: MODEL 7435, LOT# NFT056354P| EXTENSION: MODEL 3095, LOT# NAH022657V| LEAD: MODEL 3889, LOT# J0424924V| IMPLANTED:| LEAD: MODEL 3889, LOT# J0546512V| IMPLANTED:| EXTENSION: MODEL 3095, LOT# NAH025695V| IMPLANTED: |