FDA Adverse Event
Injury
Summary report: N
PASSIVE PLUS
MDR report key: 2905230
·
Received January 9, 2013
Report
- Report Number
- 2017865-2013-00496
- Event Type
- Injury
- Date Received
- January 9, 2013
- Date of Event
- May 12, 2009
- Manufacturer
- ST JUDE MEDICAL CARDIAC RHYTHM MANAGEMENT DIVISION
- Product Code
- NVN
- PMA / PMN Number
- P960030
- Removal / Correction Number
- NA
- Adverse Event
- Yes
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Occupation
- OTHER HEALTH CARE PROFESSIONAL
Narratives
Additional Manufacturer Narrative · 1
NO MEDWATCH FORM WAS RECEIVED.
Description of Event or Problem · 1
IT WAS REPORTED THAT THE ATRIAL LEAD EXHIBITED ELEVATED THRESHOLDS SINCE IMPLANT. THE LEAD HAD POOR SENSING. DURING THE ATTEMPT TO REMOVE THE LEAD THE TIP BROKE OFF AND REMAINED IN THE PATIENT'S HEART. A PARTIAL LEAD WAS EXPLANTED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 11213 | PASSIVE PLUS | PERMANENT PACEMAKER ELECTRODE | NVN | ST JUDE MEDICAL CARDIAC RHYTHM MANAGEMENT DIVISION | 1342T/52 | NA |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 79 YR | Required Intervention |