FDA Adverse Event
Malfunction
Summary report: N
RESTORE ULTRA
MDR report key: 1841898
·
Received September 20, 2010
Report
- Report Number
- 3004209178-2010-07097
- Event Type
- Malfunction
- Date Received
- September 20, 2010
- Date of Event
- August 19, 2010
- Report Date
- August 19, 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
- MN, US
- Reporter Occupation
- NOT APPLICABLE
Narratives
Additional Manufacturer Narrative · 1
(B)(4). ANALYSIS RESULTS WERE NOT AVAILABLE AT THE TIME OF THIS REPORT. A FOLLOW-UP REPORT WILL BE SENT WHEN ANALYSIS IS COMPLETED.
Description of Event or Problem · 1
IT WAS REPORTED THAT AN IMPLANTABLE NEUROSTIMULATOR (INS) DID NOT POWER ON. UPON INTERROGATION, IT GAVE A POWER-ON-RESET (POR) CONDITION. THE DEVICE WAS NEVER USED ON A PATIENT. THE PROCEDURE WAS COMPLETED USING ANOTHER INS. THE DEVICE WAS RETURNED. ADDITIONAL INFORMATION HAS BEEN REQUESTED, BUT WAS NOT AVAILABLE AS OF THE DATE OF THIS REPORT.
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 |