FDA Adverse Event
Malfunction
Summary report: N
INTERSTIM
MDR report key: 2061871
·
Received April 5, 2011
Report
- Report Number
- 3004209178-2011-02576
- Event Type
- Malfunction
- Date Received
- April 5, 2011
- Date of Event
- January 1, 2011
- Report Date
- March 10, 2011
- Manufacturer
- MDT PUERTO RICO OPERATIONS CO., JUNCOS
- Product Code
- EZW
- PMA / PMN Number
- P970004
- Adverse Event
- Yes
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- MN, US
- Reporter Occupation
- NOT APPLICABLE
Narratives
Additional Manufacturer Narrative · 1
(B)(4).
Description of Event or Problem · 1
THE PATIENT EXPERIENCED A SHOCKING SENSATION FOLLOWING A FALL. IMPEDANCE MEASUREMENTS SHOWED >4000 OHMS ON SOME OF THE BIPOLAR LEADS. ADDITIONAL INFORMATION WAS REQUESTED. SEE MANUFACTURER REPORT # 3004209178-2011-02577.
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 | 58 YR | EXPLANTED:| EXTENSION: MODEL 3095, LOT# NAH001726V| IMPLANTED:| PROGRAMMER: MODEL 3031A, LOT# NGM002845P| IMPLANTED:| EXPLANTED:| LEAD: MODEL 3886, LOT# J0206519V |