FDA Adverse Event
Injury
Summary report: N
RESTORE ULTRA
MDR report key: 2250618
·
Received September 9, 2011
Report
- Report Number
- 3004209178-2011-07632
- Event Type
- Injury
- Date Received
- September 9, 2011
- Report Date
- August 18, 2011
- Manufacturer
- MEDTRONIC PUERTO RICO OPERATIONS CO., JUNCOS
- Product Code
- LGW
- PMA / PMN Number
- P840001
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- MT, US
- Reporter Occupation
- PHYSICIAN
Narratives
Additional Manufacturer Narrative · 1
(B)(4).
Description of Event or Problem · 1
IT WAS REPORTED THAT THE PT HAD AN ALLERGIC REACTION. THE HCP WAS NOT SURE WHAT THE ROOT CAUSE WAS, BUT STATED THAT THE PT WAS IN A FULL-BLOWN BREAK OUT AND WAS MEDICATED. AN ALLERGY TEST COULD NOT BE PERFORMED FOR 30 DAYS. ADD'L INFO HAS BEEN REQUESTED, BUT WAS NOT AVAILABLE AS OF THE DATE OF THIS REPORT.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | RESTORE ULTRA | LGW | MEDTRONIC PUERTO RICO OPERATIONS CO., JUNCOS | 37712 | NA |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Required Intervention | LEAD: MODEL 39565-65, LOT # V712260018| EXPLANTED:| ACCESSORY: MODEL 37752, LOT #NKA149198N| IMPLANTED: |