FDA Adverse Event
Injury
Summary report: N
INTERSTIM II
MDR report key: 3355641
·
Received September 18, 2013
Report
- Report Number
- 3004209178-2013-16522
- Event Type
- Injury
- Date Received
- September 18, 2013
- Report Date
- August 26, 2013
- 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
- NURSE
Narratives
Additional Manufacturer Narrative · 1
(B)(4)
Additional Manufacturer Narrative · 1
CONCOMITANT PRODUCTS: PRODUCT ID 3037, SERIAL# (B)(4), PRODUCT TYPE PROGRAMMER, PATIENT; PRODUCT ID 3 093-28, LOT# V900974, IMPLANTED: (B)(6) 2012, PRODUCT TYPE LEAD. (B)(4).
Description of Event or Problem · 1
IT WAS REPORTED THE PATIENT WAS IN THE OPERATING ROOM TO HAVE A LEAD REVISION AND THERE WAS IN ISSUE WITH THE IMPLANTABLE NEUROSTIMULATOR (INS) SUSPECTED. IT WAS STATED STIMULATION WAS HELPING
Description of Event or Problem · 1
ADDITIONAL INFORMATION RECEIVED REPORTED THAT THERE WAS A LEAD BREAK AND THE CAUSE OF THE ISSUE WAS UNKNOWN. A LEAD REPLACEMENT WAS DONE, AND REPLACEMENT OCCURRED ON 2013-(B)(6). THE PATIENT DID NOT REQUIRE HOSPITALIZATION AND RECOVERED WITHOUT SEQUELAE.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 470002 | INTERSTIM II | STIMULATOR, ELECTRICAL, IMPLANTABLE, FOR INCONTINENCE | EZW | MEDTRONIC MED REL MEDTRONIC PUERTO RICO | 3058 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Required Intervention |