FDA Adverse Event
Malfunction
Summary report: N
RESTORE ADVANCED RECHARGEABLE
MDR report key: 2041419
·
Received March 24, 2011
Report
- Report Number
- 3004209178-2011-02270
- Event Type
- Malfunction
- Date Received
- March 24, 2011
- Date of Event
- March 9, 2011
- Report Date
- March 9, 2011
- Manufacturer
- MDT PUERTO RICO OPERATIONS CO., JUNCOS
- Product Code
- LGW
- PMA / PMN Number
- P840001
- 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
RECEIVED INFO THE PHYSICIAN WAS UNABLE TO INSERT THE LEAD INTO THE FRONT SLOT 0-7, BUT THE SAME LEAD WOULD GO INTO THE DISTAL SLOT 8-15. THE INS WAS NOT IMPLANTED, A NEW INS WAS USED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | RESTORE ADVANCED RECHARGEABLE | LGW | MDT PUERTO RICO OPERATIONS CO., JUNCOS | 37713 | NA |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |