FDA Adverse Event
Injury
Summary report: N
INTERSTIM II
MDR report key: 1812506
·
Received August 16, 2010
Report
- Report Number
- 3004209178-2010-06147
- Event Type
- Injury
- Date Received
- August 16, 2010
- Date of Event
- July 26, 2010
- Report Date
- July 16, 2010
- Manufacturer
- MDT PUERTO RICO OPERATIONS CO., JUNCOS
- Product Code
- EZW
- PMA / PMN Number
- P970004
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- TX, US
- Reporter Occupation
- NOT APPLICABLE
Narratives
Additional Manufacturer Narrative · 1
(B)(4).
Description of Event or Problem · 1
IT WAS REPORTED THAT PATIENT COMPLAINED OF INTERMITTENT STIMULATION, A LOSS OF THERAPEUTIC EFFECT, SEVERE PAIN IN HER LEFT HIP WHERE THE IMPLANTED DEVICE WAS, AND SWELLING AND REDNESS AT THE DEVICE SITE. PATIENT FELL ON THE IMPLANT A WEEK AGO. PATIENT HAD BILATERAL IMPLANTED DEVICES, AND HAD A REVISION OF THE DEVICE SYSTEM ON THE LEFT SIDE.
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 | 45 YR | Required Intervention | EXPLANTED:| LOT#NJY147363H| IMPLANTED:| IMPLANTED:| PROGRAMMER: MODEL 3037, LOT#NJD106138N| IMPLANTABLE NEURO STIMULATOR: MODEL 3058,| LEAD: MODEL 3093, LOT#V434086| LEAD: MODEL 3093, LOT#V440501| IMPLANTED: |