FDA Adverse Event
Injury
Summary report: N
INTERSTIM II
MDR report key: 4714422
·
Received April 21, 2015
Report
- Report Number
- 3004209178-2015-07637
- Event Type
- Injury
- Date Received
- April 21, 2015
- Report Date
- March 25, 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
- VA, US
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
PRODUCT ID 3037, SERIAL# (B)(4); PRODUCT TYPE PROGRAMMER, PATIENT PRODUCT ID 3058, SERIAL# (B)(4), IMPLANTED: 2012 (B)(6); PRODUCT TYPE IMPLANTABLE NEUROSTIMULATOR PRODUCT ID 3889-28, LOT# V915103, IMPLANTED: 2012 (B)(6); PRODUCT TYPE LEAD PRODUCT ID 3037, SERIAL# (B)(4), IMPLANTED: 2008 (B)(6); PRODUCT TYPE PROGRAMMER, PATIENT PRODUCT ID 3889-28, LOT# V151154, IMPLANTED: 2008 (B)(6); PRODUCT TYPE LEAD. (B)(4).
Description of Event or Problem · 1
IT WAS REPORTED THAT A HEALTH CARE PROVIDER (HCP) STATED THAT THE DEVICE WAS NOT PUT IN CORRECTLY AND THEY WERE GOING TO REPLACE IT. THE PATIENT PASSED AWAY DUE TO AN UNRELATED ISSUE AND THE DEVICE WAS NEVER REPLACED. REFER TO MANUFACTURER¿S REPORT # 3004209178-2015-07636 FOR THE PATIENT¿S OTHER INS.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 261953 | INTERSTIM II | STIMULATOR, ELECTRICAL, IMPLANTABLE, FOR INCONTINENCE | EZW | MEDTRONIC MED REL MEDTRONIC PUERTO RICO | 3058 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Required Intervention |