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

Model Number 37602

Device Problems High impedance (1291); Device Displays Incorrect Message (2591); Device Operates Differently Than Expected (2913); Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Therapeutic Effects, Unexpected (2099); Therapeutic Response, Decreased (2271); Complaint, Ill-Defined (2331)

Event Date 02/28/2016

Event Type  Injury  

Manufacturer Narrative

Continuation of d11: product id 37602, lot# serial#(b)(4), implanted: 2016 (b)(6) explanted: product type implantable neurostimulator.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

Information was received from a health care provider (hcp) via a manufacturer representative (rep) regarding a patient who was implanted with a neurostimulator for obsessive compulsive disorder (ocd) and movement disorders.It was reported that there were high impedance unipolar values greater than 2,000 ohms and bipolar values greater than 4,000 ohms; an open circuit on contact #0 was reported.It was confirmed that impedances were normal following an implantable neurostimulator (ins) replacement surgery in (b)(6) 2016.It was also reported that the patient was not receiving the intended therapeutic benefit from the device as there was a gradual return of ocd symptoms for the last 9 months.No troubleshooting could be performed due to a lack of access to the product.It was later reported that the patient experienced an unspecified sensation at the ins site.High impedance values greater than 40,000 ohms were reported on contact 0.The rep stated that during programming they received a charge density warning "at above 6.5v, 150 pw, 745 ohms".The hcp is planning on conducting an exploratory surgery due to the impedance issue.It was later reported that the rep met with the patient and reprogrammed them from c+,0-,1- to c+,1- and increased the pulse width from 120 to 150.An x-ray was also performed that confirmed that no physical damage was present.A possible revision of the lead and extension was discussed as no causality could be determined for the return of symptoms and the impedance issues; the issue was still ongoing.Please see report number 3004209178-2016-24266.

Manufacturer Narrative

Analysis results were not available as of the date of this report.A follow-up report will be submitted when analysis is complete.(b)(4).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

It was later reported that both of the patient's inss were replaced due to normal battery depletion.No further complications are anticipated.

Manufacturer Narrative

Analysis of the implantable neurostimulator (ins) found no significant anomalies.Analysis determined that the output and telemetry were acceptable; however, the battery is near normal battery depletion.Due to the reported complaint, an impedance test was performed in 0.9% saline solution and good impedances were observed using an n'vision clinician programmer.A lab functional test determined there was good stable output on the electrode pairs the ins had when it was received.A lab functional test determined there was good stable output on all electrode pairs.Analysis determined there were no issues when pressing on the ins can.Analysis determined the telemetry was acceptable.The information obtained from the ins upon receipt indicated the device had reached eri (elective replacement indicator).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.

• 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
• Manufacturer (Section G): MEDTRONIC PUERTO RICO OPERATIONS CO.; road 31, km. 24, hm 4; ceiba norte industrial park; juncos PR 00777
• Manufacturer Contact: lisa woodward clark ; 7000 central avenue ne rcw215; minneapolis, MN 55432 ; 7635263920
• MDR Report Key: 6110119
• MDR Text Key: 60240518
• Report Number: 3004209178-2016-24268
• Device Sequence Number: 1
• Product Code: MFR
• UDI-Device Identifier: 00613994761057
• UDI-Public: 00613994761057
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: H050003
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup,Followup,Followup
• Report Date: 08/02/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/17/2016
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 01/14/2018
• Device Model Number: 37602
• Device Catalogue Number: 37602
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/05/2017
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 07/14/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 07/20/2016
• 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): Required Intervention
• Patient Age: 62 YR