FDA Adverse Event
Injury
Summary report: N
TELIGEN
MDR report key: 2173136
·
Received July 23, 2011
Report
- Report Number
- 2124215-2011-10298
- Event Type
- Injury
- Date Received
- July 23, 2011
- Date of Event
- May 27, 2011
- Report Date
- September 23, 2011
- Manufacturer
- GUIDANT CRM CLONMEL IRELAND
- Product Code
- LWS
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
ADDITIONAL INFORMATION RECEIVED NOTED THAT THIS PATIENT HAD A HEMATOMA. NO FURTHER ACTION WAS TAKEN AND THE SYSTEM REMAINS IMPLANTED.
Additional Manufacturer Narrative · 1
SHOULD ADDITIONAL INFORMATION BECOME AVAILABLE THIS INVESTIGATION WILL BE UPDATED.
Description of Event or Problem · 1
BOSTON SCIENTIFIC RECEIVED INFORMATION THAT THIS PATIENT IMPLANTED WITH THIS DEVICE PRESENTED WITH A POST SURGICAL INFECTION. THE DEVICE POCKET WAS SWOLLEN AND ANTIBIOTICS WERE ADMINISTERED. THE PATIENT IS SCHEDULED FOR A FOLLOW UP. NO ADVERSE PATIENT EFFECTS WERE ASSOCIATED WITH THE ANTIBIOTICS GIVEN.
Description of Event or Problem · 1
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Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | TELIGEN | IMPLANTABLE CARDIOVERTER DEFIBRILLATOR | LWS | GUIDANT CRM CLONMEL IRELAND | F110 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 0185| F110| 0181 |