FDA Adverse Event
Malfunction
Summary report: N
CAPSURE FIX
MDR report key: 3151733
·
Received June 7, 2013
Report
- Report Number
- 2649622-2013-05644
- Event Type
- Malfunction
- Date Received
- June 7, 2013
- Date of Event
- March 1, 2013
- Report Date
- March 1, 2013
- Manufacturer
- MPRI
- Product Code
- NVN
- PMA / PMN Number
- P090013
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- PA, 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): THE FULL LEAD WAS RETURNED AND NO ANOMALIES WERE FOUND. THE PROXIMAL CONDUCTOR WAS KINKED/BUCKLED AND THE LEAD APPEARED TO HAVE BEEN DAMAGED AT IMPLANT. (B)(4).
Description of Event or Problem · 1
IT WAS REPORTED THAT, DURING IMPLANT, THE PHYSICIAN WAS UNABLE TO FIND A STABLE POSITION AND EXPERIENCED MULTIPLE DISLODGEMENTS WITH BOTH LEADS. BOTH LEADS WERE REMOVED 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 |
|---|---|---|---|---|---|---|---|
| 252608 | CAPSURE FIX | DRUG ELUTING PERMANENT RIGHT VENTRICULAR (RV) OR RIGHT ATRIAL (RA) PACEMAKER ELE | NVN | MPRI | 5086MRI52 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 00063 YR | 690R34, HEART RING |