FDA Adverse Event
Injury
Summary report: N
ENDOTAK RELIANCE
MDR report key: 4132316
·
Received October 1, 2014
Report
- Report Number
- 2124215-2014-14739
- Event Type
- Injury
- Date Received
- October 1, 2014
- Date of Event
- July 2, 2014
- Report Date
- July 20, 2014
- Manufacturer
- CPI - DEL CARIBE
- Product Code
- NVY
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
(B)(4). AS NO FURTHER INFORMATION CONCERNING THIS REPORT IS EXPECTED, OUR INVESTIGATION IS COMPLETE. THIS INVESTIGATION WILL BE UPDATED SHOULD FURTHER INFORMATION BE PROVIDED.
Description of Event or Problem · 1
BOSTON SCIENTIFIC RECEIVED INFORMATION THAT THIS PATIENT DEVELOPED A PNEUMOTHORAX ONE-DAY POST-IMPLANT REQUIRING INSERTION OF A CATHETER CHEST TUBE. BOSTON SCIENTIFIC RECEIVED INFORMATION THAT DURING THE IMPLANT PROCEDURE, THE PHYSICIAN HAD SOME DIFFICULTY ADVANCING THE LEAD PAST THE TRICUSPID VALUE; HOWEVER, ONCE ACROSS THE VALVE, THE LEAD WAS POSITIONED WITHOUT DIFFICULTY. SUBSEQUENTLY, BOSTON SCIENTIFIC RECEIVED INFORMATION THAT THIS ISSUE RESOLVED 12-DAYS LATER.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 613201 | ENDOTAK RELIANCE | NVY | CPI - DEL CARIBE | 0293 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 62 YR | Hospitalization| L| R | N140| 0293| 4542| 5076 |