FDA Adverse Event
Injury
Summary report: N
RESTORE PRIME ADVANCED
MDR report key: 1872785
·
Received October 14, 2010
Report
- Report Number
- 3004209178-2010-07970
- Event Type
- Injury
- Date Received
- October 14, 2010
- Date of Event
- August 1, 2010
- Report Date
- September 17, 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
- IL, US
- Reporter Occupation
- NOT APPLICABLE
Narratives
Additional Manufacturer Narrative · 1
(B)(4).
Description of Event or Problem · 1
IT WAS REPORTED PATIENT WAS STILL EXPERIENCING PROBLEMS IN HER BACK. PATIENT VISITED HER PHYSICIAN AND DISCUSSED THIS EVENT WITH A COMPANY REPRESENTATIVE. THE DEVICE WAS NOT REPROGRAMMED SUCCESSFULLY. THE PATIENT WAS SCHEDULED TO HAVE SURGERY ON (B)(6) 2010, TO FIX THE PROBLEM. IT WAS NOTED, PATIENT WAS NO LONGER HAVING ISSUES WITH HER DEVICE. ADDITIONAL INFORMATION WAS REQUESTED AND WILL BE PROVIDED WHEN IT BECOMES AVAILABLE.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | RESTORE PRIME ADVANCED | LGW | MDT PUERTO RICO OPERATIONS CO., JUNCOS | 37702 | NA |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 72 YR | Required Intervention | EXPLANTED:| IMPLANTED:| PROGRAMMER: MODEL 37743, LOT# NKE130924N| IMPLANTED:| LEAD: MODEL 39565-65, LOT# N210267002| EXPLANTED: |