FDA Adverse Event
Injury
Summary report: N
RESTORE PRIME ADVANCED
MDR report key: 1022589
·
Received April 1, 2008
Report
- Report Number
- 3004209178-2008-01696
- Event Type
- Injury
- Date Received
- April 1, 2008
- Date of Event
- February 1, 2008
- Report Date
- March 3, 2008
- Manufacturer
- MEDTRONIC PUERTO RICO OPERATIONS CO.
- Product Code
- LGW
- PMA / PMN Number
- P840001
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- MN, US
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
.
Description of Event or Problem · 1
THE REPRESENTATIVE REPORTED, A POCKET INFECTION WAS SUSPECTED AND EXPLORATORY SURGERY WAS ANTICIPATED (THE DATE WAS NOT PROVIDED). NO OTHER PATIENT SYMPTOMS WERE REPORTED. THE PHYSICIAN HAD INQUIRED OF THE FIELD STAFF IF THE PRODUCT COULD BE REMOVED, PLUGGED, IMMERSED IN STERILIZING SOLUTION AND RE-IMPLANTED. IF THE DEVICE WAS EXPLANTED, THE PHYSICIAN WAS ADVISED TO IMPLANT A NEW DEVICE. ADDITIONAL INFORMATION HAS BEEN REQUESTED FROM THE PHYSICIAN.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | RESTORE PRIME ADVANCED | LGW | MEDTRONIC PUERTO RICO OPERATIONS CO. | 37702 | NA |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Required Intervention | EXPLANTED:| EXPLANTED:| LEAD MODEL 39565| EXTENSION MODEL 37081| IMPLANTED:| EXPLANTED:| IMPLANTED:| IMPLANTED:| EXTENSION MODEL 37081| PROGRAMMER MODEL 37742 |