FDA Adverse Event
Injury
Summary report: N
2124215-2010-23798
MDR report key: 1952800
·
Received January 7, 2011
Report
- Report Number
- 2124215-2010-23798
- Event Type
- Injury
- Date Received
- January 7, 2011
- Date of Event
- December 3, 2010
- Report Date
- December 3, 2010
- Manufacturer
- GUIDANT PUERTO RICO BV
- Product Code
- LWS
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- GA
- Reporter Occupation
- MEDICAL EQUIPMENT COMPANY TECHNICIAN/REPRESENTATIVE
Narratives
Additional Manufacturer Narrative · 1
THE BOSTON SCIENTIFIC PACEMAKER REMAINS ACTIVELY IMPLANTED AND THERE ARE NO ALLEGATIONS AGAINST THE PRODUCT PERFORMANCE OF THE DEVICE. NO OTHER ADVERSE EVENTS HAVE BEEN REPORTED. THIS ISSUE WILL BE RE-EVALUATED IF ADDITIONAL INFORMATION IS RECEIVED.
Description of Event or Problem · 1
BOSTON SCIENTIFIC RECEIVED INFORMATION THAT DURING THE PROCEDURE TO IMPLANT THIS PACEMAKER, THE ASSOCIATED COMPETITIVE LEAD PERFORATED THE RIGHT ATRIUM. THE PATIENT WAS TAKEN BACK TO SURGERY AND THE LEAD WAS EXPLANTED AND REPLACED WITHOUT FURTHER INCIDENT.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | LWS | GUIDANT PUERTO RICO BV |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 71 YR | 4479| 4076| 5568| S602 |