FDA Adverse Event
Injury
Summary report: N
ELECTRODE, PACEMAKER, PERMANENT
MDR report key: 2955261
·
Received February 11, 2013
Report
- Report Number
- 2182208-2013-00272
- Event Type
- Injury
- Date Received
- February 11, 2013
- Report Date
- November 29, 2012
- Manufacturer
- RICE CREEK MFG
- Product Code
- DTB
- PMA / PMN Number
- K894040
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- FL, 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. (B)(4) .
Description of Event or Problem · 1
IT WAS REPORTED THAT PATIENT EXPERIENCED PALPITATIONS WITH ACTIVITY. IT WAS ALSO REPORTED THAT THERE WAS OVERSENSING NOTED ON A HIGH RATE EPISODE. RWAVE OR TWAVE OVERSENSING WAS SUSPECTED ON THE ATRIAL LEAD. REPROGRAMMING WAS PERFORMED AND THE PATIENT WALKED WITHOUT SYMPTOMS. THE LEAD 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 |
|---|---|---|---|---|---|---|---|
| 58496 | ELECTRODE, PACEMAKER, PERMANENT | DTB | RICE CREEK MFG | 4951M35V |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Required Intervention | ADSR01 IMPLANTABLE PULSE GENERATOR (IPG) |