ACTIVA
Report
- Report Number
- 3007566237-2018-01705
- Event Type
- Malfunction
- Date Received
- June 6, 2018
- Date of Event
- June 1, 2018
- Report Date
- November 9, 2020
- Manufacturer
- MEDTRONIC PUERTO RICO OPERATIONS CO.
- Product Code
- MHY
- PMA / PMN Number
- P960009
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- CH
- Reporter Occupation
- PHYSICIAN
Narratives
IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.
IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.
ADDITIONAL INFORMATION WAS RECEIVED FROM A HEALTHCARE PROVIDER (HCP). IT WAS REPORTED AN OUT OF RANGE HIGH UNIPOLAR IMPEDANCE VALUE WAS INDICATED ON THE NPU UPLOAD. 11 ¿ 2457 OHMS & 11 ¿ 2464 OHMS NO INTERVENTIONS OR OUTCOME INFORMATION WAS PROVIDED. NO SYMPTOMS OR COMPLICATIONS WERE REPORTED OR ANTICIPATED.
IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.
CONCOMITANT MEDICAL PRODUCTS: PRODUCT ID: 3708660, SERIAL# (B)(4), PRODUCT TYPE: EXTENSION. PRODUCT ID: 3389S-40, LOT# VA1J69F, PRODUCT TYPE: LEAD. IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.
IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.
IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.
OTHER APPLICABLE COMPONENTS ARE: PRODUCT ID: 3708660, SERIAL# (B)(4), IMPLANTED: (B)(6) 2015, PRODUCT TYPE: EXTENSION; PRODUCT ID: 3389S-40, LOT# VA1J69F, IMPLANTED: (B)(6) 2015, PRODUCT TYPE: LEAD. IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.
ADDITIONAL INFORMATION WAS RECEIVED FROM THE REP. IT WAS REPORTED IT HAS BEEN OUT OF RANGE PRIOR TO CONSENT. NO FURTHER COMPLICATIONS WERE REPORTED AS A RESULT OF THIS EVENT.
INFORMATION WAS RECEIVED FORM A HEALTHCARE PROFESSIONAL (HCP) OF A CLINICAL STUDY REGARDING A PATIENT IMPLANTED WITH A NEUROSTIMULATOR FOR PARKINSON'S DISEASE. IT WAS REPORTED THAT THE RIGHT ELECTRODE HAS A HIGH RESISTANCE OF > 40,000 OHMS. THERE WERE NO PATIENT SYMPTOMS ALLEGED AND NO FURTHER COMPLICATIONS ARE ANTICIPATED.
ADDITIONAL INFORMATION WAS RECEIVED. THE PRODUCT NUMBER AND THE SERIAL NUMBER WERE UPDATED. NO FURTHER COMPLICATIONS WERE REPORTED AS A RESULT OF THIS EVENT.
ADDITIONAL INFORMATION RECEIVED FROM A MANUFACTURING REPRESENTATIVE (REP) INDICATED THE CAUSE OF THE HIGH IMPEDANCE AND ACTIONS/INTE RVENTIONS TAKEN WERE NOT SPECIFIED. THE ISSUE WAS CONSIDERED RESOLVED.
ADDITIONAL INFORMATION WAS RECEIVED FROM THE HCP VIA THE MANUFACTURER REPRESENTATIVE (REP). THE IMPLANT DATE OF THE EXTENSION AND THE LEAD WAS (B)(6) 2015. THE SERIAL NUMBER OF THE INS WAS UPDATED. PATIENT AGE WAS UPDATED. WEIGHT WAS NOT COLLECTED FOR THE STUDY. THE SYMPTOMS, CAUSE, ACTIONS/INTERVENTIONS, AND RESOLUTION ALL WAS UNKNOWN AT THIS TIME. NO FURTHER COMPLICATIONS WERE REPORTED AS A RESULT OF THIS EVENT. ADDITIONAL INFORMATION WAS RECEIVED. PATIENT INFORMATION WAS UPDATED. NO FURTHER COMPLICATIONS WERE REPORTED AS A RESULT OF THIS EVENT.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 417486 | ACTIVA | STIMULATOR, ELECTRICAL, IMPLANTED, FOR PARKINSONIAN TREMOR | MHY | MEDTRONIC PUERTO RICO OPERATIONS CO. | 37612 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 64 YR |