MAUDE Adverse Event Report: MEDTRONIC PUERTO RICO OPERATIONS CO. ACTIVA; IMPLANTED SUBCORTICAL ELECTRICAL STIMULATOR (MOTOR DISORDERS)

Model Number 37612

Device Problems Low impedance (2285); Battery Problem (2885); Charging Problem (2892); Communication or Transmission Problem (2896)

Patient Problem Therapeutic Response, Decreased (2271)

Event Date 08/21/2019

Event Type  malfunction  

Manufacturer Narrative

Concomitant medical products: product id: 37751, serial#: (b)(4), product type: recharger.Product id: 37761, serial#: (b)(4), product type: recharger.If information is provided in the future, a supplemental report will be issued.

Event Description

Information was received from a manufacturer representative (rep) regarding a patient who was implanted with a neurostimulator (ins) for dystonia and movement disorders.It was reported that the desktop charger had a frayed cord.They also had an issue with recharging/finding a connection.The patient had concerns with charging the ins.They charge every 2-3 days for about 30 minutes and the last 6 sessions showed perfect coupling while charging.They stated the ins was extremely "low." as well, the patient had experienced a loss of therapy/return of symptoms.The symptoms were not related to the desktop charger or recharger issues.Replacement desktop charger and recharger was sent to the patient.The patient recharged for 40 minutes the day before and 50 minutes yesterday.Patient has no pocket issues per rep.Impedance test showed short at 0 and 1 <(><<)>50 ohms.They state they don't have impedance history.The patient had cervical dystonia, with head bobbing, she experienced a return of symptoms since 2 days ago.Rep said they tested impedances in various head positions.Left 3.6 volts, 90 pw, 130hz-689 ohms right 3.5 volts, 90, 130 hz-881 ohms.11.94 days low, 2.27 weeks empty - per recharge interval calculation left.C1 693 ohms c2 1785 c3 1985 01 50 20 1817 21 1817 30 2192 31 2192 32 2860 ohms right c8 901 ohms c9 1556 c 10 1803 c11 1767 8<(>&<)>9 1745 8<(>&<)>10 2126 8<(>&<)>11 2198 9<(>&<)>10 2532 9<(>&<)>11 2875 10<(>&<)>11 2935 aug13 26 min aug14 27 aug17 26 aug19 21 aug21 44 minutes aug22 59 min pt will recharge to 100%, and let implant go to low.To see if that is normal.No further complications were reported or anticipated with this event.

Manufacturer Narrative

Analysis of the desktop charger (serial no.(b)(4)) found that the cord was frayed.Analysis of the recharger (serial no.(b)(4)) found no anomalies.Bench testing showed full coupling boxes and normal charging of an implantable neurostimulator (ins).Concomitant medical product(s): product id: 37751, lot# serial# (b)(4), product type: recharger.Product id: 37761, lot# serial# (b)(4), product type: recharger.If information is provided in the future, a supplemental report will be issued.

Event Description

No additional information was received.

Manufacturer Narrative

Medtronic is submitting this report to comply with fda reporting regulations under 21 cfr parts 4 and 803.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 and has provided as much relevant information as is available to the company as of the submission date of this report.This report does not constitute an admission or a conclusion by fda, medtronic, or its employees that the device, medtronic, or its employee 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 regulatory reporting.Medtronic objects to the use of these words and others like them 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 received from the manufacturer¿s representative (rep), which was confirmed with the healthcare provider (hcp), reported nothing was done to resolve the short.It was noted the consumer was sent new/replacement parts and the rep.Had not heard from the consumer or the hcp¿s office stating any issues with charging or a return of symptoms.¿the cause of the short, charging issues, low battery, and return of symptoms was unknown.¿ the rep.Suggested looking at the devices that were returned to product repairs to see if there were any issues with the returned equipment (recharger and desktop charger).No further complications were anticipated.

Manufacturer Narrative

D2: please note that this device was used in an off-label manner as it was implanted for dystonia.Medtronic is submitting this report to comply with fda reporting regulations under 21 cfr parts 4 and 803.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 and has provided as much relevant information as is available to the company as of the submission date of this report.This report does not constitute an admission or a conclusion by fda, medtronic, or its employees that the device, medtronic, or its employee 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 regulatory reporting.Medtronic objects to the use of these words and others like them 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.

• Brand Name: ACTIVA
• Type of Device: IMPLANTED SUBCORTICAL ELECTRICAL STIMULATOR (MOTOR DISORDERS)
• Manufacturer (Section D): MEDTRONIC PUERTO RICO OPERATIONS CO.; road 31, km. 24, hm 4; ceiba norte industrial park; juncos PR 00777
• MDR Report Key: 8937286
• MDR Text Key: 156808417
• Report Number: 3004209178-2019-16458
• Device Sequence Number: 1
• Product Code: MRU
• UDI-Device Identifier: 00643169864238
• UDI-Public: 00643169864238
• Combination Product (y/n): N
• PMA/PMN Number: H020007
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Type of Report: Initial,Followup,Followup,Followup
• Report Date: 11/10/2020

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: 07/28/2019
• Device Model Number: 37612
• Device Catalogue Number: 37612
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 08/23/2019
• Initial Date FDA Received: 08/27/2019
• Supplement Dates Manufacturer Received: 09/09/2019; 09/23/2019; 11/10/2020
• Supplement Dates FDA Received: 09/20/2019; 10/03/2019; 11/10/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Age: 61 YR