FDA Adverse Event
Injury
Summary report: N
SYNERGY
MDR report key: 1850931
·
Received September 29, 2010
Report
- Report Number
- 3004209178-2010-07409
- Event Type
- Injury
- Date Received
- September 29, 2010
- Date of Event
- August 11, 2010
- Report Date
- August 31, 2010
- Manufacturer
- MEDTRONIC 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
Narratives
Additional Manufacturer Narrative · 1
(B)(4): THE DEVICES HAVE BEEN RETURNED TO THE MANUFACTURER FOR ANALYSIS WHICH IS NOT COMPLETE AS OF THE DATE OF THIS REPORT. A FOLLOW-UP REPORT WILL BE SENT WHEN THE ANALYSIS IS COMPLETE.
Description of Event or Problem · 1
IT WAS REPORTED THAT THE PATIENT EXPERIENCED PAIN FROM THE NEUROSTIMULATOR WHILE SITTING IN THE CAR AND ALSO WHEN LEANING ON ANY OBJECT. THE PATIENT HAD INADEQUATE PAIN RELIEF FROM THE STIMULATOR. THE PATIENT REQUESTED THAT THE STIMULATOR BE REMOVED AND DID NOT WANT A REPLACEMENT. THE ENTIRE DEVICE SYSTEM WAS EXPLANTED. THE PATIENT RESOLVED WITHOUT SEQUELAE. NO FURTHER DETAILS WERE PROVIDED 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 | MEDTRONIC PUERTO RICO OPERATIONS CO., JUNCOS | 7427 | NA |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 86 YR | Required Intervention | EXPLANTED:| IMPLANTED:| LEAD: MODEL 3487A, LOT# J0540972V| LEAD: MODEL 3487A, LOT# J0540972V| EXPLANTED:| IMPLANTED:| EXPLANTED:| IMPLANTED:| PROGRAMMER: MODEL 7435, LOT# NFT054311P| EXPLANTED:| IMPLANTED:| EXTENSION: MODEL 7489, LOT# NHU101316V| EXPLANTED:| EXTENSION: MODEL 7489, LOT# NHU101318V| IMPLANTED: |