FDA Adverse Event
Injury
Summary report: N
RESTORE PRIME ADVANCED
MDR report key: 1892737
·
Received October 28, 2010
Report
- Report Number
- 3004209178-2010-08597
- Event Type
- Injury
- Date Received
- October 28, 2010
- Date of Event
- September 1, 2010
- Report Date
- October 3, 2010
- Manufacturer
- MDT PUERTO RICO OPERATIONS CO., JUNCOS
- Product Code
- LGW
- PMA / PMN Number
- P840001
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- MN, US
- Reporter Occupation
- NOT APPLICABLE
Narratives
Additional Manufacturer Narrative · 1
(B)(4).
Description of Event or Problem · 1
IT WAS REPORTED, THE PT HAD AN INFECTION FOURTEEN DAYS AFTER THE IMPLANT OF THEIR DEVICE. IT WAS STATED, THE PT'S HEALTH CARE PROVIDER WAS CONSIDERING REMOVING THE PT'S DEVICE SYSTEM. ADDITIONAL INFO HAS BEEN REQUESTED, A F/U REPORT WILL BE SENT IF ADDITIONAL INFO 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 | 30 YR | Other | EXPLANTED:| IMPLANTED:| EXTENSION: MODEL 37083, LOT# NKC003144V| IMPLANTED:| EXPLANTED:| PROGRAMMER: MODEL 37743, LOT# NKE154742N| EXPLANTED:| LEAD: MODEL 3986A, LOT# N223405| IMPLANTED: |