PULSE-GENERATOR, DUAL CHAMBER, IMPLANTABLE
Report
- Report Number
- 6000031-2013-00001
- Event Type
- Injury
- Date Received
- January 22, 2013
- Date of Event
- January 15, 2013
- Report Date
- January 15, 2013
- Manufacturer
- MEDTRONIC MILACA, INC.
- Product Code
- LWS
- PMA / PMN Number
- P820003
- Adverse Event
- Yes
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- UT, US
- Reporter Occupation
- HEALTH PROFESSIONAL
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: 5388 (B)(4): THE GENERATOR WAS RETURNED AND ANALYSIS DID NOT CONFIRM THE CUSTOMER COMMENT THAT THE GENERATOR PACED FASTER THAN THE RATE IT WAS SET TO. ANALYSIS DID FIND THE UPPER AND LOWER CASES, ONE SIDE BAIL COVER, THE RING COVER AND THE BATTERY DRAWER WERE BROKEN, THE BATTERY RELEASE, HEART LEAD FLEX, ONE SIDE BAIL COVER AND THE RING COVER WERE CONTAMINATED, THE LEAD FLEX COVER WAS CORRODED, THE BATTERY CONTACTS WERE COMPRESSED AND THE SERIAL NUMBER LABEL WAS TORN. (B)(4).
THE INFORMATION SUBMITTED REFLECTS ALL RELEVANT DATA RECEIVED. IF ADDITIONAL RELEVANT INFORMATION IS RECEIVED, A SUPPLEMENTAL REPORT WILL BE SUBMITTED. (B)(4).
IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.
IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.
IT WAS REPORTED BY THE HEALTHCARE PROFESSIONAL THE EXTERNAL PULSE GENERATOR (EPG) WAS PACING AT ONE-HUNDRED-FORTY BEATS PER MINUTE (BPM) WHEN THE EPG WAS SET TO ONE-HUNDRED-THIRTY BPM. THE EPG WAS CHANGED-OUT FOR A DIFFERENT EPG. THE EPG WILL BE RETURNED TO THE MANUFACTURER FOR ANALYSIS. NO PATIENT COMPLICATIONS WERE REPORTED AS A RESULT OF THIS EVENT.
IT WAS REPORTED BY THE HEALTHCARE PROFESSIONAL THE EXTERNAL PULSE GENERATOR (EPG) WAS PACING AT ONE-HUNDRED-FORTY BEATS PER MINUTE (BPM) WHEN THE EPG WAS SET TO ONE-HUNDRED-THIRTY BPM. THE EPG WAS CHANGED-OUT FOR A DIFFERENT EPG. THE EPG WILL BE RETURNED TO THE MANUFACTURER FOR ANALYSIS. NO PATIENT COMPLICATIONS WERE REPORTED AS A RESULT OF THIS EVENT.
IT WAS FURTHER REPORTED THAT THE GENERATOR HAD BEEN RETURNED FOR SERVICE.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 31007 | PULSE-GENERATOR, DUAL CHAMBER, IMPLANTABLE | LWS | MEDTRONIC MILACA, INC. | 5388 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Required Intervention |