ACTIVA
Report
- Report Number
- 3004209178-2019-01582
- Event Type
- Malfunction
- Date Received
- January 23, 2019
- Date of Event
- January 16, 2019
- Report Date
- February 4, 2019
- Manufacturer
- MEDTRONIC PUERTO RICO OPERATIONS CO.
- Product Code
- MHY
- UDI-DI
- 00643169105492
- PMA / PMN Number
- P960009
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- CH
- Reporter Occupation
- OTHER
Narratives
REVIEW OF THIS MDR AND/OR ADDITIONAL INFORMATION RECEIVED SHOWS THAT THERE IS NO INFORMATION TO REASONABLY SUGGEST THAT THE DEVICE IN THIS REPORT MAY HAVE CAUSED OR CONTRIBUTED TO A DEATH OR SERIOUS INJURY OR THAT THE DEVICE IN THIS REPORT HAS MALFUNCTIONED. THEREFORE, THIS EVENT DID NOT AND DOES NOT MEET THE REPORTING REQUIREMENTS STIPULATED IN 21 CFR 803. 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 RECEIVED FROM THE CLINICAL SITE VIA A REP INCLUDED ADDITIONAL IMPEDANCE INFORMATION. IMPEDANCE INFORMATION AT 0.7 AMPLITUDE: C <(>&<)> 0 1938 C <(>&<)> 1 1739 C <(>&<)> 2 1775 C <(>&<)> 3 1421 C <(>&<)> 8 2192 C <(>&<)> 9 1369 C <(>&<)> 10 1835 C <(>&<)> 11 1602 0 <(>&<)> 1 2139 0 <(>&<)> 2 2870 0 <(>&<)> 3 2726 1 <(>&<)> 2 2051 1 <(>&<)> 3 2316 2 <(>&<)> 3 1846 8 <(>&<)> 9 2234 8 <(>&<)> 10 3313 8 <(>&<)> 11 3223 9 <(>&<)> 10 1922 9 <(>&<)> 11 2192 10 <(>&<)> 11 2139 ***MDR DECISION CORRECTED TO NOT REPORTABLE. NO ADDITIONAL SUPPLEMENTALS REQUIRED UNLESS ADDITIONAL INFORMATION RECEIVED INDICATES REPORTABLE EVENT. ***
INFORMATION WAS RECEIVED FROM A HEALTHCARE PROVIDER (HCP) VIA A MANUFACTURING REPRESENTATIVE (REP) REGARDING A PATIENT WITH AN IMPLANTABLE NEUROSTIMULATOR (INS). IT WAS REPORTED THAT THE PATIENT HAD A HIGH UNIPOLAR IMPEDANCE. THERE WERE NO KNOWN INTERVENTIONS AND THE EVENT WAS ONGOING. NO PATIENT SYMPTOMS OR FURTHER COMPLICATIONS WERE REPORTED AS A RESULT OF THIS EVENT. IMPEDANCE INFORMATION: C & 8 2192 OHMS.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 65323 | ACTIVA | STIMULATOR, ELECTRICAL, IMPLANTED, FOR PARKINSONIAN TREMOR | MHY | MEDTRONIC PUERTO RICO OPERATIONS CO. | 37612 | 00643169105492 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 47 YR |