FDA Adverse Event
Injury
Summary report: N
CAPSURE SP
MDR report key: 3160267
·
Received June 10, 2013
Report
- Report Number
- 2649622-2013-07968
- Event Type
- Injury
- Date Received
- June 10, 2013
- Date of Event
- March 23, 2013
- Report Date
- March 25, 2013
- Manufacturer
- MPRI
- Product Code
- DTB
- PMA / PMN Number
- P850089
- Adverse Event
- Yes
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- MN, 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: PRODUCT ID 5024 IMPLANTABLE PACING LEAD, IMPLANTED (B)(6) 1997; PRODUCT ID UNKNOWN COMPETITOR IMPLANTABLE PULSE GENERATOR (IPG), IMPLANTED (B)(6) 2004. (B)(4).
Description of Event or Problem · 1
IT WAS REPORTED THAT THE ATRIAL IMPLANTABLE PACING LEAD WAS UNDERSENSING P-WAVES. THE LEAD WAS CAPPED AND REPLACED. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 260585 | CAPSURE SP | ELECTRODE, PACEMAKER, PERMANENT | DTB | MPRI | 5524 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 00079 YR | Hospitalization| R |