FDA Adverse Event
Injury
Summary report: N
CAPSURE SP
MDR report key: 3071783
·
Received April 22, 2013
Report
- Report Number
- 2649622-2013-05302
- Event Type
- Injury
- Date Received
- April 22, 2013
- Report Date
- February 14, 2013
- Manufacturer
- MPRI
- Product Code
- DTB
- PMA / PMN Number
- P850089
- Adverse Event
- Yes
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- KS, US
- Reporter Occupation
- PHYSICIAN
Narratives
Additional Manufacturer Narrative · 1
THE INFORMATION SUBMITTED REFLECTS ALL RELEVANT DATA RECEIVED. IF ADDITIONAL RELEVANT INFORMATION IS RECEIVED, A SUPPLEMENTAL REPORT WILL BE SUBMITTED. PRODUCT ID: 4068-52 IMPLANTABLE PACING LEAD 1999 (B)(6). (B)(4).
Description of Event or Problem · 1
IT WAS REPORTED THAT THERE HAVE BEEN ATRIAL LEAD WARNINGS FOR SOME TIME. THE ATRIAL LEAD SENSING HAS BEEN DISCUSSED SINCE IMPLANT AND PROGRAMMING CHANGES WERE MADE. THE RIGHT VENTRICULAR LEAD WAS OVERSENSING NOISE AND WAS REPROGRAMMED. THE LEAD CONTINUES TO HAVE OVERSENSING. BOTH THE ATRIAL AND RIGHT VENTRICULAR LEADS ARE STILL IN USE. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 171154 | CAPSURE SP | ELECTRODE, PACEMAKER, PERMANENT | DTB | MPRI | 5024M-58 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 00079 YR | Required Intervention | (B)(4) IMPLANTABLE PULSE GENERATOR |