FDA Adverse Event
Malfunction
Summary report: N
RESTORE ULTRA
MDR report key: 2081039
·
Received April 14, 2011
Report
- Report Number
- 3004209178-2011-02814
- Event Type
- Malfunction
- Date Received
- April 14, 2011
- Date of Event
- March 16, 2011
- Report Date
- March 25, 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
THE PT EXPERIENCED NO STIMULATION SENSATION FOLLOWING A FALL ON (B)(6) 2011. THE DETAILS OF THE FALL WERE UNK. THE IMPEDANCE MEASUREMENTS WITH ELECTRODE 7 WERE GREATER THAN 10,000 OHMS. THERE WERE COUPLING AND OR COMMUNICATION ISSUES. THE BATTERY VOLTAGE WAS AT 0.00 ERROR CODE 509 DISPLAYED FOLLOWING A LCC. A 5SEC PHYSICIAN MODE RECHARGE WAS ATTEMPTED BUT WOULD NOT DISPLAY ON THE RECHARGER. THE PT DID HAVE STIMULATION AND THE ISSUE WAS RESOLVED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | RESTORE ULTRA | LGW | MDT PUERTO RICO OPERATIONS CO., JUNCOS | 37712 | NA |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 38 YR | LEAD: MODEL 3888, LOT# V394049| LEAD: MODEL 3777, LOT#V197016008| PROGRAMMER: MODEL 37743, LOT# NKE134523N| IMPLANTED:| IMPLANTED:| EXPLANTED:| EXPLANTED:| LEAD: MODEL 3888, LOT# V321642| EXPLANTED:| ACCESSORY: MODEL 37752, LOT# NKA133878N| IMPLANTED: |