FDA Adverse Event
Other
Summary report: N
MINIATURE
MDR report key: 2699014
·
Received August 13, 2012
Report
- Report Number
- 1218087-2012-00012
- Event Type
- Other
- Date Received
- August 13, 2012
- Manufacturer
- PACE MEDICAL, INC.
- Product Code
- JOQ
- PMA / PMN Number
- K870323
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- UK
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
DEVICE RETURNED BY CUSTOMER STATING THE OUTPUT CONTROLS WERE OFF OF RANGE. DEVICE WAS INVESTIGATED AND FAULT WAS DUPLICATED. THE CONTROL KNOBS HAD BECOME LOOSE. THE KNOBS WERE REFITTED PROPERLY AND THE DEVICE WAS RECALIBRATED AND FINAL TESTED. THE PACEMAKER PASSED ALL TESTS AND WAS RETURNED TO THE CUSTOMER. OBSERVATION MAY HAVE BEEN CAUSED BY ROUGH HANDLING BY HOSPITAL STAFF.
Description of Event or Problem · 1
PACE MEDICAL WAS NOTIFIED ON MARCH 29, 2011 BY (B)(4) VIA LETTER THAT UNIT HAD A FAULT.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | MINIATURE | TEMPORARY CARIDAC PACEMAKER | JOQ | PACE MEDICAL, INC. | EV4543 | NA |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |