FDA Adverse Event
Injury
Summary report: N
ALTRUA
MDR report key: 1862119
·
Received October 8, 2010
Report
- Report Number
- 2124215-2010-15734
- Event Type
- Injury
- Date Received
- October 8, 2010
- Date of Event
- July 29, 2010
- Report Date
- July 29, 2010
- Manufacturer
- GUIDANT CRM CLONMEL IRELAND
- Product Code
- NVZ
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Occupation
- HEALTH PROFESSIONAL
Narratives
Additional Manufacturer Narrative · 1
ACCORDING TO BOSTON SCIENTIFIC CRM RECORDS, THIS DEVICE IS STILL IN SERVICE. SHOULD ADDITIONAL INFORMATION BECOME AVAILABLE, THIS EVENT WOULD BE UPDATED AS NECESSARY.
Description of Event or Problem · 1
BOSTON SCIENTIFIC CRM RECEIVED INFORMATION THAT THIS PATIENT REPORTED THAT HER PACEMAKER STARTED ERODING AT THE POCKET SITE, THEREFORE THE PHYSICIAN MOVED THE DEVICE SUB PECTORAL. THE PATIENT WAS QUESTIONING IF THEY PUT IN A NEW DEVICE. OUR COMPANY'S RECORDS SHOW THIS DEVICE IS STILL IMPLANTED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | ALTRUA | IMPLANTABLE PULSE GENERATOR | NVZ | GUIDANT CRM CLONMEL IRELAND | S603 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 62 YR | Required Intervention | 4088| 4087| S603 |