ACTIVA
Report
- Report Number
- 3004209178-2018-11809
- Event Type
- Injury
- Date Received
- May 24, 2018
- Date of Event
- March 7, 2018
- Report Date
- June 6, 2018
- Manufacturer
- MEDTRONIC MED REL MEDTRONIC PUERTO RICO
- Product Code
- MHY
- UDI-DI
- 00613994761057
- PMA / PMN Number
- P960009
- Adverse Event
- Yes
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- MN, US
- Reporter Occupation
- OTHER
Narratives
IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.
INFORMATION REFERENCES THE MAIN COMPONENT OF THE SYSTEM AND OTHER APPLICABLE COMPONENTS ARE: PRODUCT ID: 7482A51, SERIAL# (B)(4), PRODUCT TYPE: EXTENSION. PRODUCT ID: 3389S-40, LOT# V253613, PRODUCT TYPE: LEAD. INFORMATION REFERENCES THE MAIN COMPONENT OF THE SYSTEM. OTHER RELEVANT DEVICE(S) ARE: PRODUCT ID: 7482A51, SERIAL/LOT #:(B)(4), UBD: (B)(6)2013, UDI#: (B)(4); PRODUCT ID: 3389S-40, SERIAL/LOT #: (B)(4), UBD: (B)(6) 2012, UDI#: (B)(4). IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.
ADDITIONAL INFORMATION WAS RECEIVED FROM THE REP INDICATING THE CAUSE OF THE SHORT CIRCUIT WAS NOT DETERMINED. THE REP NOTED THAT PRIOR TO THE SURGERY, THE NURSE HAD TO PROGRAM AROUND THE SHORT CIRCUIT. IT WAS ALSO REPORTED THAT THE EXTENSION WAS EXPLANTED AND DISCARDED AS IT WAS CUT INTO TWO SECTIONS IN ORDER TO EXPLANT IT FROM THE PATIENT. THE LEAD WAS TESTED WITH ALLIGATOR CLIP WHERE NO SHORT CIRCUIT WAS DETECTED. IT WAS ALSO NOTED THAT THE IMPEDANCES WERE NORMAL AFTER NEW EXTENSION WAS CONNECTED TO THE LEAD AND IPG., AND THE REP WOULD NOT KNOW FOR CERTAIN FOR CERTAIN IF THE SHORT CIRCUIT WAS RESOLVED UNTIL THE PATIENT IS PROGRAMMED IN THE OUTPUT CLINIC.
INFORMATION WAS RECEIVED FROM A MANUFACTURER'S REPRESENTATIVE (REP) REGARDING A PATIENT WHO WAS IMPLANTED WITH AN IMPLANTABLE NEURO STIMULATOR (INS) FOR DYSTONIA AND MOVEMENT DISORDERS. IT WAS REPORTED THAT THE ELECTIVE REPLACEMENT INDICATOR (ERI) WAS NOTED ON THE CLINICIAN PROGRAMMER BUT BATTERY VOLTAGE WAS AT 2.81V. THE REP WAS CONCERNED AND WANTED TO KNOW IF THEY SHOULD REPLACE THE BATTERY WITH THAT VOLTAGE. THERE WAS NO ALLEGATION OF DISSATISFACTION WITH LONGEVITY. IT WAS REVIEWED FOR THE REP HOW PROGRAMMED PARAMETERS COULD AFFECT LONGEVITY, FURTHER DISCUSSING THAT ONCE THE BATTERY IS FLIPPED , IT CANNOT BE DISABLED. IT WAS REVIEWED THAT INS BOUNCE BACK WHEN HIGH DRAW SCENARIO IS REMOVED, FURTHER INFORMATION WAS PROVIDED TO THE REP TO BETTER UNDERSTAND SCENARIO AFTER THE TECHNICAL SPECIALIST EXPLAINED POSSIBLE BATTERY BOUNCE BACK GIVEN ERI NOTIFICATION. IT WAS ALSO REPORTED THAT THE NEUROLOGIST NOTED THAT THERE WAS A SHORT ON CONTACTS 2/3 ON THE LEFT INS AND BATTERY VOLTAGE WAS AT 2.71V AND ON (B)(6) 2018 THE VOLTAGE WAS 2.81V. THE BATTERY READING WAS AT 2.81V ON THE DAY OF THE REPORT, PATIENT WAS ON GROUP A. IT APPEARS THE NEUROLOGIST CHANGED PROGRAMMING ON GROUP A TO C+0-1- WHICH WOULD EXPLAIN THE INS BATTERY BOUNCE BACK TO 2.81V. NO PATIENT FALLS/TRAUMAS OR ELECTROMAGNETIC INTERFERENCE (EMI) ACTIVITY WERE REPORTED. IT WAS NOTED THAT PATIENT WAS UNDERGOING SURGERY TODAY TO REPLACE THE INS, FURTHER STATING THAT THE LEAD AND EXTENSION WOULD BE TESTED TODAY TO DETERMINE WHERE THE SHORT WAS LOCATED AND THEY WOULD REPLACE THE EXTENSION AS WELL IF NECESSARY. THEY WERE HOPING IT WAS NOT THE LEAD. NO PATIENT SYMPTOMS WERE REPORTED. NO FURTHER PATIENT COMPLICATIONS WERE REPORTED/ ANTICIPATED AS A RESULT OF THIS EVENT.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 383802 | ACTIVA | STIMULATOR, ELECTRICAL, IMPLANTED, FOR PARKINSONIAN TREMOR | MHY | MEDTRONIC MED REL MEDTRONIC PUERTO RICO | 37602 | 00613994761057 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 46 YR | Required Intervention |