FDA Adverse Event
Injury
Summary report: N
INTERSTIM II
MDR report key: 2032374
·
Received March 28, 2011
Report
- Report Number
- 3004209178-2011-02325
- Event Type
- Injury
- Date Received
- March 28, 2011
- Date of Event
- February 1, 2011
- Report Date
- March 18, 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
- WA, US
- Reporter Occupation
- NOT APPLICABLE
Narratives
Additional Manufacturer Narrative · 1
(B)(4).
Description of Event or Problem · 1
IT WAS REPORTED THAT THE PATIENT EXPERIENCED NO STIMULATION SENSATION AND A LOSS OF THERAPEUTIC EFFECT. THE PATIENT VISITED THE HEALTH CARE PROVIDER, WAS STILL HAVING PROBLEMS WITH THE DEVICE SYSTEM, AND WAS SCHEDULED TO HAVE SURGERY ON (B)(6) 2011. ADDITIONAL INFORMATION HAS BEEN REQUESTED, 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 II | EZW | MEDTRONIC PUERTO RICO OPERATIONS CO., JUNCOS | 3058 | NA |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 56 YR | Required Intervention | IMPLANTED:| PROGRAMMER: MODEL 3037, LOT# NJD106936N| LEAD: MODEL 3093, LOT# V536342| EXPLANTED: |