FDA Adverse Event
Injury
Summary report: N
INTERSTIM II
MDR report key: 3408576
·
Received October 14, 2013
Report
- Report Number
- 3004209178-2013-19091
- Event Type
- Injury
- Date Received
- October 14, 2013
- Report Date
- September 23, 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
- IL, US
- Reporter Occupation
- HEALTH PROFESSIONAL
Narratives
Additional Manufacturer Narrative · 1
PRODUCT ID: 3093-28, LOT# V161901, IMPLANTED: (B)(6) 2009, EXPLANTED: (B)(6) 2013, 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 THE WHOLE SYSTEM WAS REMOVED BECAUSE IT ¿MALFUNCTIONED.¿ NO SPECIFICS WERE PROVIDED. ADDITIONAL INFORMATION HAS BEEN REQUESTED, A FOLLOW UP REPORT WILL BE SENT IF ADDITIONAL INFORMATION IS RECEIVED.
Description of Event or Problem · 1
ADDITIONAL INFORMATION RECEIVED REPORTED THE PATIENT THOUGHT IT SIMPLY "WASN'T HELPING ANYMORE" PRIOR TO BEING SCHEDULED FOR EXPLANT. IT WAS STATED THE PATIENT DID NOT EXPERIENCE SYMPTOMS AND NO TROUBLESHOOTING WAS DONE. THE PATIENT WAS "FINE" FOLLOWING THE EXPLANT.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 525992 | INTERSTIM II | STIMULATOR, ELECTRICAL, IMPLANTABLE, FOR INCONTINENCE | EZW | MEDTRONIC MED REL MEDTRONIC PUERTO RICO | 3058 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 00025 YR | Required Intervention |