MAUDE Adverse Event Report: MEDTRONIC MED REL MEDTRONIC PUERTO RICO ACTIVA; STIMULATOR, ELECTRICAL, IMPLANTED, FOR PARKINSONIAN TREMOR

Model Number 37612

Device Problems High impedance (1291); Malposition of Device (2616); Charging Problem (2892); Communication or Transmission Problem (2896)

Patient Problem Pain (1994)

Event Date 10/08/2014

Event Type  Injury  

Event Description

It was reported the patient was unable to recharge their device.The charging efficiency did not improve from zero.It was unknown whether it was a stimulator defect or a problem with the depth of the implant.The patient had been trained and was able to demonstrate effective recharging.The device could be charged but the box remained white.It was unknown if the patient was using cycling or continuous mode.The device was removed and it was able to charge with a maximum efficiency of 8 displayed.Upon adjusting the implant position to a shallower one and recharging the device the same number 8 was confirmed.After the revision there were no more problems and the device could be charged.The depth of the implant was the cause of the event.It was noted there was no product defect.There was no injury to the patient and the event was considered solved at the time.A couple of weeks after the procedure the patient was having trouble getting good coupling with the recharger again.The patient could no longer get any black boxes on the recharger, but the device could communicate.An antenna locate function was attempted but they were only able to get 40.They considered the possibility of a malfunctioning recharger but a spare recharger was used and the right stimulator was able to get six boxes while the left stimulator did not improve and showed zero.Recharging the right stimulator usually required two to thirty minutes but it was noticed it reached full charge in three minutes.After they charged the right stimulator they recharged the left.It was noted the remaining charge level on the left was shown as 4/4 when the remaining battery level was checked with the recharger.For safety a new recharger was sent to the patient.The same events happened with a new recharger.It was confirmed that when charging began the box was still white but the device could be charged.Device interrogation revealed the amount of battery was 100%.It was also confirmed there were no abnormalities when therapy impedance was measured.Device interrogation reports did indicate high impedances, contact three had impedances greater than 30,000.The patient did complain of pain near the pocket.The event cause was undetermined.It was unknown how the patient was doing.Outcome was unknown at the time of report.Additional follow-up is being conducted to obtain this information.A follow-up report will be sent if additional information is received.

Event Description

Additional information reported there were no abnormalities with the resistance value and the battery was at 75%.They tried charging it but could not confirm with their eyes that the box displayed a 2.The antenna locate value was at most 44 the week of october 24 but had shifted from 40 to around 50 the day of interrogation.The follow up examinations were performed because there was a possibility that the charging efficiency would improve in the future.Outcome was still unknown at the time of report.A follow-up report will be sent if additional information is received.

Event Description

Additional information reported there was bad charge efficiency.The patient visited the hospital since the new charger did not improve the situation.The charging efficiency was checked.The measured value with the antenna locator mode was 40-44.The boxes were still all white but charging was confirmed to be possible.The battery remaining level was 100% on the clinician programmer and the charging history was confirmed.The therapy impedance was measured and it was within normal range.The charge efficiency was not over two boxes.Due to the bad charge efficiency continuing for three months the physician requested the file to be analyzed.During follow up in (b)(6) 2015, it was noted the ¿gauge¿ displayed 2 during charging more frequently but never displayed 4.The physician indicated the hematoma around the stimulator may be having an effect.Despite changing the charger position and angle a display of greater than 2 could not be confirmed.Charging efficiency was 8 for the device on the right side and max of 2 boxes on the left.The battery never went below 50% because the patient charged frequently.Depth, hematoma, and device turnover were unlikely.Physician noted both a hematoma and that a hematoma was unlikely at this time it was not clear if the hematoma was present.It was also confirmed the stimulator had not flipped.

Event Description

Additional information reported an x-ray was performed and it was confirmed that the stimulator had been flipped in the body.The decrease in charging efficiency was due to the flipped stimulator.The stimulator and adaptor were replaced.Following the replacement the charging efficiency was checked and was confirmed to be charging fully.All eight boxes were in black.Impedance was measured prior to the procedure and was shown to be high on contact 3.After the operation was completed impedance was measured and normal values on all electrodes were confirmed.It was noted ¿the lead was cut off from the extension so the situation was not the same as the lead had been implanted and possibility of anomaly connection between the extension and the pocket adaptor was considered.¿ there was no telemetry since the physician stopped conducting telemetry on the way prior to the replacement operation.The replacement was completed without issue.

Manufacturer Narrative

Concomitant medical products: product id: 37612, serial# (b)(4), implanted: (b)(6) 2014, product type: implantable neurostimulator.(b)(4).

Manufacturer Narrative

(b)(4).

Manufacturer Narrative

The previously reported conclusion no longer applies to this event.

Event Description

Additional information indicated the x-ray showed a possible kink but it was not confirmed.If additional information is received a follow-up report will be sent.

Manufacturer Narrative

(b)(4).

Event Description

Additional information reported the stimulator had flipped.The device was to be replaced.If additional information is received a follow-up report will be sent.

Manufacturer Narrative

Analysis of the implantable neurostimulator (ins) serial number (b)(4) found no significant anomaly.The ins was functionally okay with insignificant anomalies.Analysis of the stimulation adapter serial number (b)(4) found that the body conductor was broken within 10 cm of connector area.The number 3 conductor was broken 2.8 cm from the proximal end.Circuit number 3 was open.There were no shorts between circuits.Analysis of the stimulation plug/boot found that the connector was crushed.(b)(4).

Event Description

Additional information received from a healthcare professional of a clinical study updated the onset date to (b)(6) 2014.Seriousness was updated to hospitalization or longer stay for treatment.It was noted that they were taking a wait and see approach as it was decided the charging efficiency may improve, patient was under observation.Patient's medical history included depression/melancholy.

• Brand Name: ACTIVA
• Type of Device: STIMULATOR, ELECTRICAL, IMPLANTED, FOR PARKINSONIAN TREMOR
• Manufacturer (Section D): MEDTRONIC MED REL MEDTRONIC PUERTO RICO; ceiba norte industrial park, r; juncos PR 00777
• Manufacturer (Section G): MEDTRONIC NEUROMODULATION; 7000 central avenue ne rcw215; minneapolis MN 55432
• Manufacturer Contact: diane wolf ; 7000 central avenue ne rcw215; minneapolis, MN 55432 ; 7635263987
• MDR Report Key: 4232913
• MDR Text Key: 5000200
• Report Number: 3004209178-2014-21094
• Device Sequence Number: 1
• Product Code: MRU
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: H020007
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Study,Health Professional,Company Representative,company represent
• Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup,Followup,Followup
• Report Date: 10/14/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 04/28/2014
• Device Model Number: 37612
• Device Catalogue Number: 37612
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/17/2015
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 05/19/2015
• Initial Date FDA Received: 11/06/2014
• Supplement Dates Manufacturer Received: Not provided; Not provided; Not provided; Not provided; Not provided; Not provided; Not provided
• Supplement Dates FDA Received: 11/13/2014; 02/18/2015; 03/25/2015; 04/03/2015; 04/16/2015; 05/13/2015; 05/20/2015
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 06/12/2013
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Required Intervention
• Patient Age: 00057 YR