FDA Adverse Event
Injury
Summary report: N
INTEGRITY RX
MDR report key: 4053369
·
Received September 3, 2014
Report
- Report Number
- 9612164-2014-01163
- Event Type
- Injury
- Date Received
- September 3, 2014
- Report Date
- September 3, 2014
- Manufacturer
- MEDTRONIC IRELAND
- Product Code
- MAF
- PMA / PMN Number
- P030009
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Occupation
- PATIENT
Narratives
Additional Manufacturer Narrative · 1
EVALUATION: RESULTS: INHERENT RISK OF PROCEDURE (CORONARY ARTERY OCCLUSION). UNKNOWN (INSUFFICIENT INFORMATION). NO RESULTS AVAILABLE SINCE NO EVALUATION WAS PERFORMED. CONCLUSION: KNOWN INHERENT RISK OF PROCEDURE (CORONARY ARTERY OCCLUSION). UNKNOWN (INSUFFICIENT INFORMATION). UNABLE TO CONFIRM COMPLAINT. (B)(4).
Additional Manufacturer Narrative · 1
(B)(4)
Description of Event or Problem · 1
A PATIENT CONTACTED THE LIFELINE HELP DESK IN ORDER TO OBTAIN ADDITIONAL INFORMATION ON VISITS TO THE HOSPITAL FOLLOWING THE IMPLANTATION OF AN INTEGRITY BARE METAL STENT. THE PATIENT REPORTED THAT THE STENT WAS 'CLOGGED' AND THAT THIS NECESSITATED FOLLOW-UP VISITS TO THE HOSPITAL. THE PATIENT WAS ADVISED TO REQUEST THAT THE PHYSICIAN OBTAINED THE MEDICAL RECORDS.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 538555 | INTEGRITY RX | STENT, CORONARY | MAF | MEDTRONIC IRELAND | 0005972822 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Hospitalization |