FDA Adverse Event
Malfunction
Summary report: N
CAPSURE SP
MDR report key: 3071697
·
Received April 22, 2013
Report
- Report Number
- 2649622-2013-05216
- Event Type
- Malfunction
- Date Received
- April 22, 2013
- Report Date
- February 12, 2013
- Manufacturer
- MPRI
- Product Code
- DTB
- PMA / PMN Number
- P830061
- Adverse Event
- Yes
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- NJ, 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: E2DR01AA IMPLANTABLE PULSE GENERATOR (B)(6) 2005. (B)(4).
Additional Manufacturer Narrative · 1
CORRECTED INFORMATION: NO EVAL EXPLAIN CODE. IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.
Description of Event or Problem · 1
IT WAS REPORTED THAT THE VENTRICULAR LEAD HAD LOW IMPEDANCE AND A POLARITY SWITCH. THE LEAD WAS EXPLANTED 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 |
|---|---|---|---|---|---|---|---|
| 171628 | CAPSURE SP | ELECTRODE, PACEMAKER, PERMANENT | DTB | MPRI | 4024 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 00076 YR | Hospitalization| R | 4068 IMPLANTABLE PACING LEAD |