FDA Adverse Event
Malfunction
Summary report: N
INTERSTIM II
MDR report key: 4840959
·
Received June 12, 2015
Report
- Report Number
- 3004209178-2015-11542
- Event Type
- Malfunction
- Date Received
- June 12, 2015
- Report Date
- May 26, 2015
- Manufacturer
- MEDTRONIC MED REL MEDTRONIC PUERTO RICO
- Product Code
- EZW
- PMA / PMN Number
- P970004
- Adverse Event
- Yes
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- TX, US
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
CONCOMITANT MEDICAL DEVICES: PRODUCT ID: 3037, SERIAL# (B)(4), PRODUCT TYPE: PROGRAMMER, PATIENT. PRODUCT ID: 3 889-28, LOT# V989274, IMPLANTED: (B)(6) 2012, PRODUCT TYPE LEAD. (B)(4).
Description of Event or Problem · 1
THE PATIENT REPORTED THAT COMPATIBILITY GUIDELINES WERE REQUESTED FOR THE FOLLOWING: TENS OR OTHER EXTERNAL STIMULATION. THE PATIENT HAS SPINAL STENOSIS, PRIOR TO INTERSTIM. COMPATIBILITY GUIDELINES WERE REQUESTED FOR THE FOLLOWING: MRI. IT WAS NOTED THAT THE PATIENT WAS GOING EVERY 15 MINUTES. THE PATIENT HAD RELIEF UNTIL ABOUT A YEAR AGO, WHEN HIS CARDIO RX LYSICS, 80MG. NO OUTCOME WAS REPORTED REGARDING THIS EVENT. FURTHER FOLLOW-UP IS BEING CONDUCTED TO OBTAIN THIS INFORMATION. IF ADDITIONAL INFORMATION IS RECEIVED, A FOLLOW-UP REPORT WILL BE SENT.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 386405 | INTERSTIM II | STIMULATOR, ELECTRICAL, IMPLANTABLE, FOR INCONTINENCE | EZW | MEDTRONIC MED REL MEDTRONIC PUERTO RICO | 3058 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 00071 YR |