FDA Adverse Event
Injury
Summary report: N
INTERSTIM II
MDR report key: 3221010
·
Received July 11, 2013
Report
- Report Number
- 3004209178-2013-11619
- Event Type
- Injury
- Date Received
- July 11, 2013
- Report Date
- June 17, 2013
- Manufacturer
- MEDTRONIC MED REL MEDTRONIC PUERTO RICO
- Product Code
- EZW
- PMA / PMN Number
- P970004
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- MN, US
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
CONCOMITANT MEDICAL PRODUCTS: PRODUCT ID 3889-33, LOT# VA062D8, IMPLANTED: (B)(6) 2013, EXPLANTED: (B)(6) 2013. PRODUCT TYPE: LEAD: PRODUCT ID 3037, SERIAL# (B)(4), IMPLANTED: (B)(6) 2009. PRODUCT TYPE: PROGRAMMER, PATIENT: PRODUCT ID 3093-28, LOT# V222578, IMPLANTED: (B)(6) 2009. PRODUCT TYPE: LEAD. (B)(4).
Description of Event or Problem · 1
IT WAS REPORTED THAT EVERYTHING WAS REPLACED AS THE PATIENT HAD AN INFECTION. IF ADDITIONAL INFORMATION IS RECEIVED, A FOLLOW UP REPORT WILL BE SENT.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 319475 | INTERSTIM II | STIMULATOR, ELECTRICAL, IMPLANTABLE, FOR INCONTINENCE | EZW | MEDTRONIC MED REL MEDTRONIC PUERTO RICO | 3058 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 00056 YR | Required Intervention |