FDA Adverse Event
Injury
Summary report: N
INTERSTIM II
MDR report key: 1851146
·
Received September 30, 2010
Report
- Report Number
- 3004209178-2010-07484
- Event Type
- Injury
- Date Received
- September 30, 2010
- Date of Event
- September 2, 2010
- Report Date
- September 2, 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
- MN, US
- Reporter Occupation
- NOT APPLICABLE
Narratives
Additional Manufacturer Narrative · 1
(B)(4)
Description of Event or Problem · 1
IT WAS REPORTED PT LOST STIMULATION COMPLETELY DESPITE INCREASING STIMULATION TO THE HIGHEST LEVEL POSSIBLE. IT WAS NOTED ASSOCIATED LOSS OF CLINICAL RESPONSE. PHYSICIAN STATED ON PT'S X-RAY THERE WAS EVIDENCE OF SIGNIFICANT ENTANGLEMENT OF THE LEAD JUST PROXIMAL TO ITS CONNECTION WITH THE IMPLANTABLE PULSE GENERATOR (IPG). A LEAD FRACTURE WAS SUSPECTED. IT WAS NOTED THERE WAS NO KNOWN TRAUMA. THE LEAD AND IMPLANTABLE NEURO STIMULATOR (INS) WERE EXPLANTED AND REPLACED. ADDITIONAL INFO WAS REQUESTED AND WILL BE PROVIDED WHEN IT BECOMES AVAILABLE.
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 | 50 YR | Required Intervention | IMPLANTED:| EXPLANTED:| LEAD: MODEL 3093, LOT# B0890461K |