FDA Adverse Event
Injury
Summary report: N
RESOLUTE INTEGRITY RX
MDR report key: 2924475
·
Received January 22, 2013
Report
- Report Number
- 9612164-2013-00089
- Event Type
- Injury
- Date Received
- January 22, 2013
- Report Date
- December 26, 2012
- Manufacturer
- MEDTRONIC IRELAND
- Product Code
- NIQ
- PMA / PMN Number
- P110013
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- FL, US
- Reporter Occupation
- PATIENT FAMILY MEMBER OR FRIEND
Narratives
Additional Manufacturer Narrative · 1
RESULTS: ALLERGIC REACTION. IT APPEARS THAT THE PATIENT MAY HAVE BEEN ALLERGIC TO PLAVIX, ALTHOUGH THIS IS UNCONFIRMED. DEVICE OR PROCEDURAL IMAGES NOT PROVIDED FOR REVIEW. CONCLUSION: ALLERGIC REACTION. IT APPEARS THAT THE PATIENT MAY HAVE BEEN ALLERGIC TO PLAVIX, ALTHOUGH THIS IS UNCONFIRMED. DEVICE OR PROCEDURAL IMAGES NOT PROVIDED FOR REVIEW. (B)(4).
Description of Event or Problem · 1
POST IMPLANT OF A RESOLUTE INTEGRITY DRUG ELUTING STENT THE PATIENT HAD EXPERIENCED ITCHING FROM THE INSIDE OUT, AND SKIN PEELING. ADDITIONAL INFORMATION PROVIDED CONFIRMS THE PHYSICIAN TOOK THE PATIENT OFF PLAVIX AND THE PEELING AND ITCHING HAS STOPPED. PATIENT IS NOT ALLERGIC TO NICKEL AND IS NOW FEELING WELL.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 31198 | RESOLUTE INTEGRITY RX | STENT, CORONARY, DRUG-ELUTING | NIQ | MEDTRONIC IRELAND |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Required Intervention |