FDA Adverse Event
Injury
Summary report: N
CONFIRM
MDR report key: 5310169
·
Received December 18, 2015
Report
- Report Number
- 3010215456-2015-32775
- Event Type
- Injury
- Date Received
- December 18, 2015
- Date of Event
- October 21, 2015
- Report Date
- October 21, 2015
- Manufacturer
- ST. JUDE MEDICAL, INC. (CRM-KISTA)
- Product Code
- MXC
- PMA / PMN Number
- K081365
- Adverse Event
- Yes
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- GM
- Reporter Occupation
- PHYSICIAN
- Health Professional
- N
Narratives
Additional Manufacturer Narrative · 1
(B)(4).
Description of Event or Problem · 1
IT WAS REPORTED THAT DURING A FOLLOW UP, THE IMPLANTABLE CARDIAC MONITOR COULD NOT BE INTERROGATED USING TWO DIFFERENT MERLIN PROGRAMMERS. NO INTERVENTION OR PATIENT SYMPTOMS WERE REPORTED.
Description of Event or Problem · 1
NEW INFORMATION STATES THE IMPLANTABLE CARDIAC MONITOR HAS BEEN EXPLANTED.
Description of Event or Problem · 1
MEW INFORMATION STATED THAT THE PATIENT CONDITION WAS STABLE POST PROCEDURE.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 838404 | CONFIRM | IMPLANTABLE CARDIAC MONITOR | MXC | ST. JUDE MEDICAL, INC. (CRM-KISTA) | DM2100 | 4234332 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | NA | Female | Required Intervention |