FDA Adverse Event
Injury
Summary report: N
INTERSTIM II
MDR report key: 4092914
·
Received September 16, 2014
Report
- Report Number
- 3004209178-2014-17091
- Event Type
- Injury
- Date Received
- September 16, 2014
- Report Date
- September 4, 2014
- Manufacturer
- MEDTRONIC PUERTO RICO OPERATIONS CO.
- Product Code
- EZW
- PMA / PMN Number
- P970004
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- NY, US
- Reporter Occupation
- PHYSICIAN
Narratives
Additional Manufacturer Narrative · 1
CONCOMITANT MEDICAL PRODUCTS: PRODUCT ID: 3889-28, LOT# VA0KU57, IMPLANTED: (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 THE PATIENT HAD A 50% OR GREATER SYMPTOM REDUCTION. EVENT CAUSE WAS DETERMINED, NOTED AS NOT DEVICE RELATED. THE PATIENT DEVELOPED WOUND INFECTION. THE PATIENT HAD A HISTORY OF PREVIOUS (B)(6). THE PATIENT (ILLEGIBLE) EXPLANT (B)(6) 2014. THE PATIENT WAS BACK TO BASELINE, STIM REMOVAL. THEY WERE CONSIDERING POSSIBLE SINGLE STAGE REIMPLANT IN 3 - 4 MONTHS.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 573108 | INTERSTIM II | STIMULATOR, ELECTRICAL, IMPLANTABLE, FOR INCONTINENCE | EZW | MEDTRONIC PUERTO RICO OPERATIONS CO. | 3058 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 00053 YR | Required Intervention |