FDA Adverse Event
Injury
Summary report: N
INTERSTIM
MDR report key: 2120148
·
Received June 6, 2011
Report
- Report Number
- 3004209178-2011-03995
- Event Type
- Injury
- Date Received
- June 6, 2011
- Date of Event
- January 1, 2011
- Report Date
- May 6, 2011
- Manufacturer
- MEDTRONIC PUERTO RICO OPERATIONS CO., JUNCOS
- Product Code
- EZW
- PMA / PMN Number
- P970004
- Adverse Event
- Yes
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- AL, US
- Reporter Occupation
- PHYSICIAN
Narratives
Additional Manufacturer Narrative · 1
(B)(4).
Description of Event or Problem · 1
THE PATIENT EXPERIENCED A LOSS OF STIMULATION SENSATION AND A RETURN OF URINARY INCONTINENCE. IMPEDANCES > 1000 OHMS WERE MEASURED ON ALL ELECTRODES. THE LEAD INSULATION HAD BROKEN. THE IMPLANTABLE NEUROSTIMULATOR AND LEAD WERE EXPLANTED AND REPLACED. THE PATIENT RECOVERED WITHOUT SEQUELA. A FOLLOW-UP REPORT WILL BE SENT IF ADDITIONAL INFORMATION BECOMES AVAILABLE.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | INTERSTIM | EZW | MEDTRONIC PUERTO RICO OPERATIONS CO., JUNCOS | 3023 | NA |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 76 YR | Required Intervention | PROGRAMMER: MODEL 3031, LOT# NBW003235P| EXPLANTED:| IMPLANTED:| EXTENSION: MODEL 3095, LOT# NAH001482V| EXPLANTED:| LEAD: MODEL 3966, LOT# LA1262| IMPLANTED: |