INTERSTIM II
Report
- Report Number
- 3004209178-2014-08739
- Event Type
- Injury
- Date Received
- May 8, 2014
- Date of Event
- March 27, 2014
- Report Date
- April 18, 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
- MN, US
- Reporter Occupation
- PHYSICIAN
Narratives
CONCOMITANT PRODUCTS: PRODUCT ID 3889-28, LOT # V598061, IMPLANTED: (B)(6) 2011, PRODUCT TYPE LEAD; PRODUCT ID 3037, SERIAL # (B)(4), PRODUCT TYPE PROGRAMMER, PATIENT. (B)(4).
FINAL ANALYSIS OF THE LEAD REVEALED INSIGNIFICANT ANOMALIES. THE LEAD BODY WAS STRETCHED.
PRODUCT ID: 3889-28, LOT# V598061, IMPLANTED: (B)(6) 2011, EXPLANTED: (B)(6) 2014, PRODUCT TYPE: LEAD. PRODUCT ID: 3037, SERIAL# (B)(4), PRODUCT TYPE: PROGRAMMER. (B)(4). ANALYSIS RESULTS WERE NOT AVAILABLE AS OF THE DATE OF THIS REPORT. A FOLLOW-UP REPORT WILL BE SUBMITTED WHEN ANALYSIS IS COMPLETE.
IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.
IT WAS REPORTED THE LEAD HAD MOVED APPROXIMATELY 1.1 CM. NO ACTION HAD BEEN TAKEN AND THE EVEN WAS CONSIDERED ONGOING.
ADDITIONAL INFORMATION REPORTED THE BATTERY WAS REPLACED DURING THE LEAD REPLACEMENT AND THE EVENT WAS CONSIDERED RESOLVED WITHOUT SEQUELAE.
ADDITIONAL INFORMATION RECEIVED REPORTED THAT THERE WAS A RETURN OF SYMPTOMS AND LACK OF RELIEF ABOUT 40 PERCENT. THERE WAS NORMAL BATTERY DEPLETION. THERE WAS NO PATIENT DEATH OR PATIENT INJURY RELATED TO THE EVENT. THE PATENT RECOVERED WITHOUT SEQUELA.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 277555 | INTERSTIM II | STIMULATOR, ELECTRICAL, IMPLANTABLE, FOR INCONTINENCE | EZW | MEDTRONIC MED REL MEDTRONIC PUERTO RICO | 3058 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 00062 YR | Required Intervention |