FDA Adverse Event
Injury
Summary report: N
CAPSURE SP
MDR report key: 4830342
·
Received June 10, 2015
Report
- Report Number
- 2649622-2015-06159
- Event Type
- Injury
- Date Received
- June 10, 2015
- Date of Event
- April 29, 2015
- Report Date
- April 29, 2015
- Manufacturer
- MPRI
- Product Code
- DTB
- PMA / PMN Number
- P830061
- Adverse Event
- Yes
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- MO, US
- Reporter Occupation
- HEALTH PROFESSIONAL
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. (B)(4).
Description of Event or Problem · 1
IT WAS REPORTED THAT A WARNING WAS TRIGGERED DUE TO LOW IMPEDANCE ON THE RIGHT VENTRICULAR (RV) LEAD WHICH LED TO A POLARITY SWITCH WHICH LED TO POCKET STIMULATION. THERE WAS ALSO SOME OVERSENSING AND NOISE ON THE LEAD. THE LEAD WILL BE REPROGRAMMED AND IT REMAINS 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 |
|---|---|---|---|---|---|---|---|
| 374324 | CAPSURE SP | ELECTRODE, PACEMAKER, PERMANENT | DTB | MPRI | 4024-58 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 00087 YR | Required Intervention | ADSR01 IPG, 5867-3M ADAPTOR |