FDA Adverse Event
Injury
Summary report: N
INTERSTIM
MDR report key: 1911705
·
Received November 29, 2010
Report
- Report Number
- 3004209178-2010-09962
- Event Type
- Injury
- Date Received
- November 29, 2010
- Date of Event
- May 20, 2009
- Report Date
- November 18, 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
- MD, US
- Reporter Occupation
- PHYSICIAN
Narratives
Additional Manufacturer Narrative · 1
(B)(4).
Description of Event or Problem · 1
IT WAS REPORTED THAT THE PT HAD THEIR DEVICE REPLACED BECAUSE IT WAS NOT WORKING. SPECIFICALLY, THE HEALTHCARE PROFESSIONAL NOTED THAT THE DEVICE FAILED TO "REBOOT". THE PHYSICIAN HAD SEEN THE PT SINCE THE REPLACEMENT SURGERY. IF ADDITIONAL INFO BECOMES AVAILABLE, A FOLLOW-UP REPORT WILL BE SENT.
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 | 72 YR | Required Intervention | LEAD: MODEL 3093, LOT# J0421757V| EXPLANTED:| LEAD: MODEL 3093, LOT# J0421757V| IMPLANTED:| IMPLANTED:| EXPLANTED:| EXTENSION: MODEL 3095, LOT# NAH015527V| PROGRAMMER: MODEL 3037, LOT# NGM013969P| IMPLANTED: |