FDA Adverse Event
Malfunction
Summary report: N
RESTORE PRIME ADVANCED
MDR report key: 2081053
·
Received April 14, 2011
Report
- Report Number
- 3004209178-2011-02811
- Event Type
- Malfunction
- Date Received
- April 14, 2011
- Date of Event
- March 21, 2011
- Report Date
- March 21, 2011
- Manufacturer
- MDT PUERTO RICO OPERATIONS CO., JUCNOS
- 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 INFORMATION THAT WHILE IMPLANTING THE INS, THE PHYSICIAN WAS UNABLE TO ADVANCE THE LEAD INTO THE 8-16 PORT. SEVERAL ATTEMPTS WERE MADE BUT THE LEAD WOULD ONLY GO PART WAY INTO THE PORT. THE SET SCREWS WERE UNLOCKED, EVERYTHING WAS DONE THAT COULD POSSIBLY BE DONE AND STILL THE LEAD WOULD NOT ADVANCE. THE PT WAS IMPLANTED WITH ANOTHER DEVICE WITHOUT FURTHER PROBLEMS AND RECOVERED WITHOUT SEQUELA.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | RESTORE PRIME ADVANCED | LGW | MDT PUERTO RICO OPERATIONS CO., JUCNOS | 37702 | NA |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | UNK CONVERSION TYPE : MODEL WRENCHN, LOT# UNK| IMPLANTED:| EXPLANTED: |