PULSE-GENERATOR, DUAL CHAMBER, IMPLANTABLE
Report
- Report Number
- 2182208-2013-00162
- Event Type
- Injury
- Date Received
- February 9, 2013
- Date of Event
- December 7, 2012
- Report Date
- December 7, 2012
- Manufacturer
- RICE CREEK MFG
- Product Code
- LWP
- PMA / PMN Number
- P820003/S072
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- PA, US
- Reporter Occupation
- BIOMEDICAL ENGINEER
Narratives
THE INFORMATION SUBMITTED REFLECTS ALL RELEVANT DATA RECEIVED. IF ADDITIONAL RELEVANT INFORMATION IS RECEIVED, A SUPPLEMENTAL REPORT WILL BE SUBMITTED. (B)(4).
EVALUATION SUMMARY (B)(4): THE GENERATOR WAS RETURNED AND ANALYSIS CONFIRMED THE CUSTOMER COMMENT THAT THE VENTRICULAR CONNECTION PORT WOULD NOT ALLOW THE PACING CABLE TO FIT IN SECURELY, THERE WAS A PIN FOUND STUCK IN THE VENTRICULAR OUTPUT CONNECTOR. (B)(4).
IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.
IT WAS REPORTED THAT THE EXTERNAL PULSE GENERATOR (EPG) HAD A BROKEN VENTRICULAR OUTPUT CONNECTOR. IT WAS ALSO REPORTED THE VENTRICULAR CONNECTION PORT WILL NOT ALLOW PACING CABLE TO FIT SECURELY. THE EPG WAS RETURNED FOR REPAIR. THERE WAS NO PATIENT INVOLVEMENT.
IT WAS REPORTED THAT THE EXTERNAL PULSE GENERATOR (EPG) HAD A BROKEN VENTRICULAR OUTPUT CONNECTOR. IT WAS ALSO REPORTED THE VENTRICULAR CONNECTION PORT WILL NOT ALLOW PACING CABLE TO FIT SECURELY. THE EPG WAS RETURNED FOR REPAIR. THERE WAS NO PATIENT INVOLVEMENT.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 57068 | PULSE-GENERATOR, DUAL CHAMBER, IMPLANTABLE | LWP | RICE CREEK MFG | 5388 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Required Intervention |