FDA Adverse Event
Injury
Summary report: N
INTERSTIM II
MDR report key: 4803392
·
Received May 28, 2015
Report
- Report Number
- 3004209178-2015-09882
- Event Type
- Injury
- Date Received
- May 28, 2015
- Report Date
- April 30, 2015
- Manufacturer
- MEDTRONIC MED REL MEDTRONIC PUERTO RICO
- Product Code
- EZW
- Adverse Event
- Yes
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- NC, US
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
CONCOMITANT MEDICAL PRODUCTS: PRODUCT ID: 3093-28, LOT# V955731, IMPLANTED: (B)(6) 2012, EXPLANTED: (B)(6) 2014, PRODUCT TYPE: LEAD. PRODUCT ID: 3037, SERIAL# (B)(4), PRODUCT TYPE: PROGRAMMER, PATIENT. (B)(4).
Description of Event or Problem · 1
IT WAS REPORTED THAT A PATIENT¿S IMPLANTABLE NEUROSTIMULATOR (INS) DIED AND ¿WAS NOTHING.¿ IT WAS AN INS ISSUE AND THERE WAS NOTHING THE PATIENT COULD DO. THE INS WAS REPLACED. THE PATIENT RECOVERED WITHOUT PERMANENT IMPAIRMENT. ADDITIONAL INFORMATION RECEIVED REPORTED THAT ONE YEAR AFTER IMPLANT THE DEVICE ¿STOPPED WORKING¿ AND THE EQUIPMENT ¿FAILED.¿ THE MANUFACTURE REPRESENTATIVE REPORTEDLY STATED THAT IT WAS DEVICE ITSELF THAT WAS THE PROBLEM. THE IMPLANTABLE NEUROSTIMULATOR AND LEAD WERE TO BE SENT BACK FOR ANALYSIS.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 345887 | INTERSTIM II | STIMULATOR, ELECTRICAL, IMPLANTABLE, FOR INCONTINENCE | EZW | MEDTRONIC MED REL MEDTRONIC PUERTO RICO | 3058 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 00058 YR | Required Intervention |