FDA Adverse Event
Malfunction
Summary report: N
PATCH
MDR report key: 2924952
·
Received January 22, 2013
Report
- Report Number
- 2124215-2013-01617
- Event Type
- Malfunction
- Date Received
- January 22, 2013
- Date of Event
- November 21, 2012
- Report Date
- November 21, 2012
- Manufacturer
- CPI - DEL CARIBE
- Product Code
- NHW
- PMA / PMN Number
- P910077
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- MI
- Reporter Occupation
- PHYSICIAN
Narratives
Additional Manufacturer Narrative · 1
ALL AVAILABLE INFORMATION INDICATES THE DEVICE REMAINS IN SERVICE. THIS INVESTIGATION WILL BE UPDATED SHOULD FURTHER INFORMATION BE PROVIDED.
Description of Event or Problem · 1
BOSTON SCIENTIFIC RECEIVED INFORMATION THAT THIS RIGHT VENTRICULAR (RV) LEAD EXHIBITED A HIGH OUT OF RANGE SHOCK IMPEDANCE MEASUREMENT. THE DAILY MEASUREMENTS SHOW IMPEDANCE AT 60-80 OHMS. BOSTON SCIENTIFIC TECHNICAL SERVICES (TS) SUGGESTED TROUBLESHOOTING OPTIONS. A NON-INVASIVE PROGRAMMED STIMULATION (NIPS) TEST WAS SCHEDULED. THERE WERE NO ADVERSE PATIENT EFFECTS REPORTED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 29944 | PATCH | IMPLANTABLE LEAD | NHW | CPI - DEL CARIBE | 0067 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 66 YR | (B)(4)| (B)(4)| N051| 4047| 0068| H220| 0067| (B)(4)| 4968 |