FDA Adverse Event
Malfunction
Summary report: N
ENRHYTHM
MDR report key: 2865031
·
Received December 10, 2012
Report
- Report Number
- 2647346-2012-01800
- Event Type
- Malfunction
- Date Received
- December 10, 2012
- Date of Event
- June 16, 2012
- Report Date
- September 28, 2012
- Manufacturer
- MDT SOFAMOR DANEK PUERTO RICO MFG
- Product Code
- NVZ
- PMA / PMN Number
- P980035/S038
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- FL, US
- Reporter Occupation
- OTHER HEALTH CARE PROFESSIONAL
Narratives
Additional Manufacturer Narrative · 1
IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.
Additional Manufacturer Narrative · 1
THE INFORMATION SUBMITTED REFLECTS ALL RELEVANT DATA RECEIVED. IF ADDITIONAL RELEVANT INFORMATION IS RECEIVED, A SUPPLEMENTAL REPORT WILL BE SUBMITTED. CONCOMITANT CONTINUED: 5034 IMPLANTABLE PACING LEAD (B)(6) 1998.
Description of Event or Problem · 1
IT WAS REPORTED THAT THE DEVICE WAS OBSERVED WITH NON-PHYSIOLOGICAL SENSING. OVERSENSING WAS NOTED WITH 41 SHORT V-V INTERVALS. THE DEVICE REMAINS IN USE WITH CONTINUED MONITORING. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | ENRHYTHM | PULSE GENERATOR, PERMANENT, IMPLANTABLE | NVZ | MDT SOFAMOR DANEK PUERTO RICO MFG | P1501DR |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 00048 YR | 5534 IMPLANTABLE PACING LEAD |