FDA Adverse Event
Injury
Summary report: N
INTEGRITY DR
MDR report key: 3923141
·
Received July 9, 2014
Report
- Report Number
- 2017865-2014-14478
- Event Type
- Injury
- Date Received
- July 9, 2014
- Date of Event
- May 14, 2014
- Manufacturer
- ST. JUDE MEDICAL, INC., CRMD
- Product Code
- LWP
- PMA / PMN Number
- NA
- Removal / Correction Number
- NA
- Adverse Event
- Yes
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- ND, US
- Reporter Occupation
- PHYSICIAN
Narratives
Additional Manufacturer Narrative · 1
PLEASE RETRACT THIS REPORT 2017865-2014-14478, THIS MEDICAL DEVICE SHOULD NOT HAVE BEEN REPORTED AS A MEDICAL DEVICE REPORT (MDR).
Additional Manufacturer Narrative · 1
ALL INFORMATION PROVIDED BY MANUFACTURER, NO MEDWATCH FORM WAS RECEIVED. DEVICE EVALUATION ANTICIPATED, BUT NOT YET BEGUN.
Description of Event or Problem · 1
UPON REVIEW, THE PULSE GENERATOR SHOULD NOT HAVE BEEN SUBMITTED AS A MEDICAL DEVICE REPORT (MDR) AND DID NOT CAUSE A SERIOUS ADVERSE EVENT, AND NOT LIKELY TO CAUSE SERIOUS INJURY UPON RECURRENCE.
Description of Event or Problem · 1
IT WAS REPORTED THAT THE PULSE GENERATOR EXHIBITED A PREMATURE ELECTIVE REPLACEMENT INDICATOR AND WAS UNABLE TO BE INTERROGATED. THE DEVICE WAS EXPLANTED AND REPLACED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 401466 | INTEGRITY DR | IMPLANTABLE PACEMAKER PULSE GENERATOR | LWP | ST. JUDE MEDICAL, INC., CRMD | 5366 | NA |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 80 YR | Required Intervention |