FDA Adverse Event
Malfunction
Summary report: N
SYNERGY
MDR report key: 2050156
·
Received April 1, 2011
Report
- Report Number
- 3004209178-2011-02487
- Event Type
- Malfunction
- Date Received
- April 1, 2011
- Date of Event
- January 1, 2011
- Report Date
- March 15, 2011
- 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
- MN, US
- Reporter Occupation
- NOT APPLICABLE
Narratives
Additional Manufacturer Narrative · 1
(B)(4).
Description of Event or Problem · 1
IT WAS REPORTED, THE PT EXPERIENCED A LOSS OF THERAPEUTIC EFFECT FOLLOWING A FALL. IT WAS STATED, THE PT HAD NO STIMULATION SENSATION ON ELECTRODES 4-7, AND STIMULATION ON ELECTRODES 0-3 ONLY AT 8.5 VOLTS OR HIGHER. THE DETAILS OF THE FALL WERE NOT REPORTED. THE PT WAS REFERRED TO THEIR HEALTH CARE PROVIDER. ADDITIONAL INFORMATION HAS BEEN REQUESTED, A F/U REPORT WILL BE SENT 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 | 57 YR | IMPLANTED:| EXPLANTED:| IMPLANTED:| LEAD: MODEL 3890, LOT# J0454797V| EXPLANTED:| EXTENSION: MODEL 7489, LOT# NHU070551V| IMPLANTED:| EXPLANTED:| EXPLANTED:| IMPLANTED:| LEAD: MODEL 3890, LOT# J0454608V| EXTENSION: MODEL 7489, LOT# NHU070550V| PROGRAMMER: MODEL 7435, LOT# NFT047435P| IMPLANTED:| EXPLANTED:| PROGRAMMER: MODEL 7435, LOT# NFT069909P| EXPLANTED:| IMPLANTED: |