FDA Adverse Event
Injury
Summary report: N
INTERSTIM
MDR report key: 1910079
·
Received November 24, 2010
Report
- Report Number
- 3004209178-2010-09924
- Event Type
- Injury
- Date Received
- November 24, 2010
- Date of Event
- November 1, 2010
- Report Date
- November 18, 2010
- Manufacturer
- MDT PUERTO RICO OPERATIONS CO., JUNCOS
- Product Code
- EZW
- PMA / PMN Number
- P970004
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Occupation
- PHYSICIAN
Narratives
Additional Manufacturer Narrative · 1
(B)(4).
Description of Event or Problem · 1
IT WAS REPORTED THAT THE PT PASSED OUT AND WAS RUSHED TO THE HOSPITAL. THE PT'S CARDIOLOGIST BELIEVED THERE MAY HAVE BEEN AN INTERACTION BETWEEN THE DEVICE AND THE PT'S PACEMAKER BECAUSE THE PACEMAKER WAS NOT PACING AT THE APPROPRIATE RATE. ADDITIONAL INFORMATION WAS REQUESTED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | INTERSTIM | EZW | MDT PUERTO RICO OPERATIONS CO., JUNCOS | 3023 | NA |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 69 YR | Other | IMPLANTED:| EXTENSION: MODEL 3095, LOT# NAH029860V| PROGRAMMER: MODEL 3037, LOT# NJD042253N| IMPLANTED:| LEAD: MODEL 3093, LOT# V003390 |