FDA Adverse Event
Injury
Summary report: N
INTERSTIM II
MDR report key: 2230559
·
Received August 12, 2011
Report
- Report Number
- 3004209178-2011-06324
- Event Type
- Injury
- Date Received
- August 12, 2011
- Date of Event
- January 1, 2010
- Report Date
- July 20, 2011
- Manufacturer
- MDT PUERTO RICO OPERATIONS CO., JUNCOS
- Product Code
- EZW
- PMA / PMN Number
- P970004
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- MN, US
- Reporter Occupation
- NOT APPLICABLE
Narratives
Additional Manufacturer Narrative · 1
(B)(4). NO DEVICE ANALYSIS WAS PERFORMED; THE DEVICE MET RISK BASED ANALYSIS CRITERIA.
Description of Event or Problem · 1
IT WAS REPORTED THAT THE PT FELT THE IMPLANTED NEUROSTIMULATOR WAS ONLY OF MINIMAL USE AND THE PT WAS GOING TO REQUIRE SPINAL MRIS IN THE FUTURE. THEREFORE, THE DEVICE WAS EXPLANTED. THE PT INCURRED NO INJURY.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | INTERSTIM II | EZW | MDT PUERTO RICO OPERATIONS CO., JUNCOS | 3058 | NA |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 46 YR | Required Intervention | EXPLANTED:| LEAD: MODEL 3093, LOT # V071011| IMPLANTED:| PROGRAMMER: MODEL 3037, LOT # NJD047413N |