FDA Adverse Event
Injury
Summary report: N
INTERSTIM
MDR report key: 1841979
·
Received September 21, 2010
Report
- Report Number
- 3004209178-2010-07154
- Event Type
- Injury
- Date Received
- September 21, 2010
- Date of Event
- August 26, 2010
- Report Date
- August 23, 2010
- 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
- NY, US
- Reporter Occupation
- NOT APPLICABLE
Narratives
Additional Manufacturer Narrative · 1
(B)(4).
Description of Event or Problem · 1
IT WAS REPORTED THAT 2 LEADS BECAME DISCONNECTED SINCE THE MIDDLE OF (B)(6) 2010. THE COMPANY REPRESENTATIVE PROGRAMMED THE REMAINING LEAD AND PATIENT HAD ADEQUATE COVERAGE. THE PATIENT WAS SCHEDULED TO REVISE THE PATIENT. THERE WAS NO KNOWN ACCIDENT OR INCIDENT RELATED TO THIS COMPLAINT. ADDITIONAL INFORMATION HAS BEEN REQUESTED AND WILL BE MADE AS FOLLOW UP AS IT BECOMES AVAILABLE.
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 | 70 YR | Required Intervention | IMPLANTED:| IMPLANTED:| LEAD: MODEL 3889, LOT# V010328| EXPLANTED:| EXPLANTED:| EXPLANTED:| PROGRAMMER: MODEL 3031A, LOT# NGM027440P| EXTENSION: MODEL 3095, LOT# NAH031003V| IMPLANTED: |