FDA Adverse Event
Injury
Summary report: N
INTERSTIM II
MDR report key: 2874062
·
Received December 14, 2012
Report
- Report Number
- 3004209178-2012-11851
- Event Type
- Injury
- Date Received
- December 14, 2012
- Report Date
- November 26, 2012
- Manufacturer
- MDT PUERTO RICO OPERATIONS CO
- Product Code
- EZW
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- FL, US
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
PRODUCT ID 3889-28, LOT# V557203, IMPLANTED: 2010 (B)(6), 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 A PATIENT EXPERIENCED PAIN AT THE POCKET SITE. THE IMPLANTABLE NEUROSTIMULATOR (INS) AND THE LEAD WERE EXPLANTED ON (B)(6) 2012 AND IT WAS STATED THAT THE PROCEDURE "WENT AS PLANNED". TWO DAYS LATER IT WAS REPORTED THAT THE DEVICE HAD BEEN WORKING FINE WITH NO DEFECTS EXCEPT THE PATIENT WAS HAVING PAIN AT THE POCKET SITE. NO FURTHER INFORMATION WAS PROVIDED. MORE INFORMATION HAS BEEN REQUESTED AND IF RECEIVED, A SUPPLEMENTAL REPORT WILL BE SENT.
Description of Event or Problem · 1
UPON FURTHER REVIEW, IT WAS NOTED THAT THIS EVENT WAS ALSO REPORTED IN MFR 3004209178-2012-10731.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | INTERSTIM II | STIMULATOR, ELECTRICAL, IMPLANTABLE, FOR INCONTINENCE | EZW | MDT PUERTO RICO OPERATIONS CO | 3058 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Required Intervention |