FDA Adverse Event
Injury
Summary report: N
CAPSURE SP NOVUS
MDR report key: 3153377
·
Received June 8, 2013
Report
- Report Number
- 2649622-2013-05974
- Event Type
- Injury
- Date Received
- June 8, 2013
- Report Date
- March 12, 2013
- Manufacturer
- MPRI
- Product Code
- DTB
- PMA / PMN Number
- P830061
- Adverse Event
- Yes
- 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. CONCOMITANT PRODUCTS: 5076 IMPLANTABLE PACING LEAD, (B)(6) 2006. (B)(4).
Description of Event or Problem · 1
IT WAS REPORTED THAT THE PATIENT IS EXPERIENCING INTERMITTENT POCKET MUSCLE STIMULATION WITH PACING. THE CHRONIC LEAD TREND WAS TURNED OFF. THE LEAD IS STILL IN USE. NO FURTHER PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 254182 | CAPSURE SP NOVUS | ELECTRODE, PACEMAKER, PERMANENT | DTB | MPRI | 4092-58 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Required Intervention | ADDR01 IMPLANTABLE PULSE GENERATOR |