MAUDE Adverse Event Report: MEDTRONIC PUERTO RICO OPERATIONS CO. ACTIVA; STIMULATOR, ELECTRICAL, IMPLANTED, FOR PARKINSONIAN TREMOR

Model Number 37612

Device Problems Electrical /Electronic Property Problem (1198); High impedance (1291); Low impedance (2285); Impedance Problem (2950); Insufficient Information (3190)

Patient Problems Muscular Rigidity (1968); Dysphasia (2195); Therapeutic Response, Decreased (2271); Dyskinesia (2363); No Known Impact Or Consequence To Patient (2692)

Event Date 07/26/2018

Event Type  malfunction  

Manufacturer Narrative

If information is provided in the future, a supplemental report will be issued.

Event Description

Information was received from a consumer regarding a patient with an implantable neurostimulator (ins) for the treatment of parkinson¿s dual and movement disorders.It was reported the caller was having a ct scan and mri to rule out a possible tumor unrelated to the device or therapy.When the deep brain stimulation (dbs) was interrogated, they found out it was compromised and there was an open circuit most likely between 1 and 2.It was reported the health care professional (hcp) was already aware and had informed the patient that they were ineligible for the mri.The patient notified the manufacturer representative on (b)(6) 2018.No symptoms or complications were reported or anticipated.Information regarding insr issues has been omitted as it is contained in pe# (b)(4).

Manufacturer Narrative

If information is provided in the future, a supplemental report will be issued.

Event Description

Additional information received from a manufacturing representative (rep) indicated there was also a short circuit.The impedance issues were not where the patient was currently programmed.The patient was doing well with their current therapy.Impedance information: left stn (3.8 ma, therapy impedance 686 ohms): monopolar: 0: 2178 ohms 1: 684 ohms 2: 678 ohms 3: 2917 ohms bipolar: 0<(>&<)>1: 1450 ohms 0<(>&<)>2: 1351 ohms 1<(>&<)>2: low 0<(>&<)>3: 4007 ohms 1<(>&<)>3: 2378 ohms 2<(>&<)>3: 2288 ohms.

Manufacturer Narrative

If information is provided in the future, a supplemental report will be issued.

Event Description

Additional information was received from the patient indicating that the dbs was implanted in (b)(6) 2016.The patient did not know what circumstances led to the open circuit, steps taken to resolve, or if it was resolved.They stated that the doctor ordered an mri and the mri's were not performed, instead 3 ct scans were performed.They also mentioned they have had 5 malfunctions in approximately 1 or 2 months with the dbs unit.

Manufacturer Narrative

If information is provided in the future, a supplemental report will be issued.

Manufacturer Narrative

If information is provided in the future, a supplemental report will be issued.

Manufacturer Narrative

If information is provided in the future, a supplemental report will be issued.

Manufacturer Narrative

If information is provided in the future, a supplemental report will be issued.

Event Description

Additional information was received: it was reported that the caller stated the patient had been experiencing issues with their leads/open circuits.The caller stated impedances had been fluctuating up and down.The caller stated the hcp had been adjusting the patient¿s programmer due to the issue, including adjusting from ¿amps¿ to ¿voltage¿ to ¿constant current.¿ the caller stated on (b)(6) 2019 the hcp changed the patient constant current mode.The caller stated they noticed the next few days the patient was slower and stiffer (return of parkinson¿s symptoms).The caller stated the patient experienced their symptoms mostly on their right side.The caller stated yesterday they went to increase the patient¿s stimulation ¿one click¿ but they couldn't increase.The caller confirmed when they tried to increase the programmer would display upper limit screen.The caller was redirected to follow up with their hcp for symptoms and programming.There were no further complications reported.

Manufacturer Narrative

Medtronic, inc.(medtronic) is submitting this report to comply with 21 c.F.R.Part 803, the medical device reporting regulation.This report is based upon information obtained by medtronic, which the company may not have been able to fully investigate or verify prior to the date the report was required by the fda.Medtronic has made reasonable efforts to obtain more complete information in the time allotted and has provided as much information as is available to the company as of the submission date this report.This report does not constitute an admission or a conclusion by fda, medtronic, or its employees that the device, medtronic or its employees caused or contributed to the event described in the report.In particular, this report does not constitute an admission by anyone that the product described in this report has any "defects" or has "malfunctioned".These words are included in the fda 3500a form and are fixed items for selection created by the fda, to categorize the type of event solely for the purpose of reporting pursuant to part 803.Medtronic objects to the use of these words and others like it because of the lack of definition and the connotations implied by these terms.This statement should be included with any information or report disclosed to the public under the freedom of information act.Any required fields that are unpopulated are blank because the information is currently unknown or unavailable.A good faith effort will be made to obtain the applicable information relevant to the report.If information is provided in the future, a supplemental report will be issued.

Event Description

Additional information was received from a rep.It was reported between his may visit and august visit, his therapy impedances dropped from 972 to 634 without explanation.The reading prior to the visit was 1010 and that was the rep's first visit with him.In (b)(6) he was reporting new right side dyskinesia and speech problems, so the rep lowered his stimulation because his current was at 4.1, up from 2.7 due to the impedance change.His symptoms resolved.On the day of the report his impedance was 643, so stable.However, the rep did a full electrode impedance check on the left which revealed: c<(>&<)>0 2043 c<(>&<)>1 665 c<(>&<)>2 665 c<(>&<)>3 2591 0<(>&<)>1 1351 0<(>&<)>2 1283 0<(>&<)>3 3401 1<(>&<)>2 37 1<(>&<)>3 1995 2<(>&<)>3 1947 the right side was normal.The patient was getting therapy with a therapy in normal range.It was also reported the patient had to replace their charger five times since (b)(6).It just kept not working.They thought they were somehow burning through it because of the open circuits and the possible short.It was unknown why they were going through chargers or how it could be related.

• Brand Name: ACTIVA
• Type of Device: STIMULATOR, ELECTRICAL, IMPLANTED, FOR PARKINSONIAN TREMOR
• Manufacturer (Section D): MEDTRONIC PUERTO RICO OPERATIONS CO.; road 31, km. 24, hm 4; ceiba norte industrial park; juncos PR 00777
• MDR Report Key: 7747128
• MDR Text Key: 116722359
• Report Number: 3004209178-2018-17360
• Device Sequence Number: 1
• Product Code: MHY
• UDI-Device Identifier: 00643169529762
• UDI-Public: 00643169529762
• Combination Product (y/n): N
• PMA/PMN Number: P960009
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,consum
• Type of Report: Initial,Followup,Followup,Followup,Followup
• Report Date: 04/25/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/03/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 02/28/2017
• Device Model Number: 37612
• Device Catalogue Number: 37612
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 04/25/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Age: 75 YR
• Patient Weight: 75