FDA Adverse Event
Injury
Summary report: N
SYNERGY
MDR report key: 2070147
·
Received April 21, 2011
Report
- Report Number
- 6000032-2011-02984
- Event Type
- Injury
- Date Received
- April 21, 2011
- Date of Event
- March 1, 2009
- Report Date
- April 4, 2011
- Manufacturer
- MDT PUERTO RICO OPERATIONS CO, MED REL
- Product Code
- LGW
- PMA / PMN Number
- P840001
- Adverse Event
- Yes
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- NY, US
- Reporter Occupation
- PHYSICIAN
Narratives
Additional Manufacturer Narrative · 1
(B)(4).
Description of Event or Problem · 1
RECEIVED INFO THE PT WAS NOT ABLE TO ADJUST STIMULATION WITH THE PT PROGRAMMER. THE STATUS LIGHTS WERE REVIEWED AND THE PT HAD REACHED THE UPPER LIMIT. PT WAS INSTRUCTED TO CONTACT HER PHYSICIAN. ADDITIONAL INFO FROM THE HCP STATED THE SYSTEM WAS NON-FUNCTIONING AND WAS REMOVED ON (B)(6) 2009. NO FURTHER INFO WAS PROVIDED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | SYNERGY | LGW | MDT PUERTO RICO OPERATIONS CO, MED REL | 7427 | B03185155H |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 53 YR | Required Intervention | EXPLANTED:| IMPLANTED:| IMPLANTED:| EXPLANTED:| EXTENSION: MODEL 7489, LOT# NHU069571V| EXTENSION: MODEL 7489, LOT# NHU069570V| IMPLANTED:| LEAD: MODEL 3998, LOT# V008387| EXPLANTED:| PROGRAMMER: MODEL 7435, LOT# NFT044305P |