FDA Adverse Event
Malfunction
Summary report: N
INTERSTIM II
MDR report key: 2061941
·
Received April 5, 2011
Report
- Report Number
- 3004209178-2011-02628
- Event Type
- Malfunction
- Date Received
- April 5, 2011
- Date of Event
- March 1, 2011
- Report Date
- March 28, 2011
- Manufacturer
- MEDTRONIC PUERTO RICO OPERATIONS CO., JUNCOS
- Product Code
- EZW
- PMA / PMN Number
- P970004
- Adverse Event
- Yes
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- MO, US
- Reporter Occupation
- NOT APPLICABLE
Narratives
Additional Manufacturer Narrative · 1
(B)(4).
Description of Event or Problem · 1
IT WAS REPORTED THAT WHILE STIMULATION WAS TURNED ON THE PATIENT EXPERIENCED A LOSS OF STIMULATION SENSATION. THE NUMBERS ON THE PATIENT'S PROGRAMMER WERE INCREASING BUT THE PATIENT WAS NOT FEELING THE CHANGE IN STIMULATION IN HER BODY. THE AMPLITUDE WAS AT 1.0 (WHICH IS NORMAL SETTING FOR THE PATIENT). THE ISSUE OCCURRED FOLLOWING A FALL ON THURSDAY WHEN THE PATIENT FELL ON THE DEVICE. THE PATIENT COLLAPSED DUE TO CHANGE IN BLOOD PRESSURE AND WAS TAKEN TO THE EMERGENCY ROOM BY AMBULANCE AND WAS ADMITTED. THE PATIENT WAS SEEM BY A PHYSICIAN AT THE HOSPITAL; HER URINE OUTPUT WAS FINE. ADDITIONAL INFORMATION WAS REQUESTED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | INTERSTIM II | EZW | MEDTRONIC PUERTO RICO OPERATIONS CO., JUNCOS | 3058 | NA |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 42 YR | EXPLANTED:| IMPLANTED:| PROGRAMMER: MODEL 3037, LOT# NJD085763N| LEAD: MODEL 3093, LOT# V248486 |