FDA Adverse Event
Injury
Summary report: N
INTERSTIM
MDR report key: 3170260
·
Received June 14, 2013
Report
- Report Number
- 3004209178-2013-10386
- Event Type
- Injury
- Date Received
- June 14, 2013
- Report Date
- May 24, 2013
- Manufacturer
- MEDTRONIC MED REL MEDTRONIC PUERTO RICO
- Product Code
- EZW
- PMA / PMN Number
- P970004
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- SC, US
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
PRODUCT ID: 3093-28, LOT# V188958, IMPLANTED: (B)(6) 2009, PRODUCT TYPE: LEAD. PRODUCT ID: 3037, SERIAL# (B)(4), IMPLANTED: (B)(6) 2009. PRODUCT TYPE: PROGRAMMER. (B)(4).
Additional Manufacturer Narrative · 1
(B)(4)
Description of Event or Problem · 1
IT WAS REPORTED THAT THE PATIENT THOUGHT SHE CURRENTLY HAD A BACTERIAL INFECTION. NO FURTHER INFORMATION WAS REPORTED. IF ADDITIONAL INFORMATION IS RECEIVED A FOLLOW-UP REPORT WILL BE SUBMITTED.
Description of Event or Problem · 1
IT WAS NOTED THAT WITH THE BACTERIAL INFECTION THE PATIENT'S STOMACH CRAMPED A LOT.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 272036 | INTERSTIM | STIMULATOR, ELECTRICAL, IMPLANTABLE, FOR INCONTINENCE | EZW | MEDTRONIC MED REL MEDTRONIC PUERTO RICO | 3023 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Required Intervention |