FDA Adverse Event
Death
Summary report: N
CONTAK RENEWAL TR
MDR report key: 1201789
·
Received October 17, 2008
Report
- Report Number
- 2124215-2008-99952
- Event Type
- Death
- Date Received
- October 17, 2008
- Date of Event
- October 4, 2008
- Report Date
- October 17, 2008
- Manufacturer
- CLONMEL
- Product Code
- NIK
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- CO, US
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
NOT RETURNED. SHOULD ANY ADD'L INFO RELATED TO THIS EVENT BECOME AVAILABLE, THIS EVENT WILL BE UPDATED.
Description of Event or Problem · 1
DURING A PROCEDURE THE PHYSICIAN ATTEMPTED TO PLACE THE LEAD ACUITY 3 TIMES, BUT IT WAS DISLODGED UPON WITHDRAWAL OF THE GUIDE CATHETER. SINCE HEMODYNAMIC STATUS OF THE PT DETERIORATED, IT WAS DECIDED NOT TO TRY FURTHER ON THE CORONARY SINUS. AS AN ALTERNATIVE, IT WAS DECIDED TO IMPLANT A TRICHAMBER DEVICE CONTAK H120. PT PRESENTED DROP IN OXYGEN SATURATION, AND WAS TAKEN TO THE INTENSIVE CARE UNIT (ICU) WHERE SHE PRESENTED RESPIRATORY ARREST. PT WAS INTUBATED, AND CPR PERFORMED WITH NORADRENALINE ADMINISTRATION. HOWEVER, AFTER 6 HOURS AT THE ICU AND CPR ADMINISTRATION, THE PT DIED IN 2008.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | CONTAK RENEWAL TR | IMPLANTABLE CHF GENERATOR | NIK | CLONMEL | H120 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Death | 7555/8050791| 4457/586128| 4555/169476| 4480/509087 |