FDA Adverse Event
Malfunction
Summary report: N
INTERSTIM II
MDR report key: 4182178
·
Received October 17, 2014
Report
- Report Number
- 3004209178-2014-19931
- Event Type
- Malfunction
- Date Received
- October 17, 2014
- Report Date
- September 24, 2014
- 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
- TX, US
- Reporter Occupation
- HEALTH PROFESSIONAL
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# V646684, IMPLANTED: (B)(6) 2011, PRODUCT TYPE: LEAD. (B)(4).
Description of Event or Problem · 1
ADDITIONAL INFORMATION RECEIVED REPORTED THAT THE PATIENT HAD A LOSS OF THERAPEUTIC EFFECT AND THE REPORTER DIDN¿T THINK THE PATIENT HAD THERAPY. IT WAS THOUGHT THAT THE IMPLANTABLE NEUROSTIMULATOR (INS) WAS TURNED OFF FOR AN MRI IN 2012 AND WAS NEVER TURNED BACK ON.
Description of Event or Problem · 1
IT WAS REPORTED THE PATIENT¿S STIMULATOR HAD NOT BEEN WORKING FOR TWO YEARS. THE PATIENT DID NOT HAVE GREATER THAN FIFTY PERCENT SYMPTOM REDUCTION. THE PATIENT HAD UNDERLYING NEUROLOGICAL DISORDERS. THE ISSUE WAS ONGOING.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 661786 | INTERSTIM II | STIMULATOR, ELECTRICAL, IMPLANTABLE, FOR INCONTINENCE | EZW | MEDTRONIC MED REL MEDTRONIC PUERTO RICO | 3058 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 00057 YR |