FDA Adverse Event
Injury
Summary report: N
RESTORE ULTRA
MDR report key: 1823461
·
Received August 25, 2010
Report
- Report Number
- 3004209178-2010-06439
- Event Type
- Injury
- Date Received
- August 25, 2010
- Date of Event
- July 1, 2010
- Report Date
- July 27, 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
- FL, US
- Reporter Occupation
- NOT APPLICABLE
Narratives
Additional Manufacturer Narrative · 1
(B)(4).
Description of Event or Problem · 1
INFO WAS RECEIVED FROM A PT REPORTING A LOSS OF THERAPEUTIC EFFECT SINCE HER LEAD REVISION SURGERY TWO WEEKS AGO. SHE INITIALLY HAD COVERAGE BUT NOW HAS NO COVERAGE IN HER BACK. HER FIRST PROGRAMMING SESSION WAS YESTERDAY. LEAD REVISION WAS DONE DUE TO LEAD MIGRATION. ADD'L INFO HAS BEEN REQUESTED AND IF RECEIVED, A F/U REPORT WILL BE SENT.
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 | UNK CONVERSION TYPE: MODEL LEADN, LOT#: UNK| IMPLANTED:| EXPLANTED: |