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

Model Number B35200

Device Problems Break (1069); High impedance (1291); Connection Problem (2900); Material Twisted/Bent (2981)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 03/13/2024

Event Type  Injury  

Manufacturer Narrative

Other relevant device(s) are: product id: 3708660.Product id: 3708660.Medtronic submits this report to comply with fda regulations 21 cfr parts 4 and 803.Medtronic has made reasonable efforts to provide 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.Any required fields that are unpopulated are blank because the information is currently unknown or unavailable.Medtronic will submit a supplemental report if additional relevant information becomes known.

Event Description

It was reported that the extension cable broke during a replacement normal battery replacement procedure.Stimulation to the affected hemisphere was discontinued.Because the patient wasn't ready to undergo full anesthesia, patient had to be left without stimulation by the affected electrode, exposing her to a risk of rebound symptoms.The plug could not be inserted into the implantable neurostimulator (ins) slot to reach its usual end position.It stopped approx 2mm short of the end position.After removing and visually inspecting the plug, it seemed slightly bent, but showed a seemingly normal flexibility.The setscrew fass loosened as far as possible.After reinserting, the same problem still existed.Impedances of contact 11 were above normal. the insulation of the extension was aged visibly, showing a yellowish color.First, the surgeon experienced problems inserting the extension plug into the percept's connector slot.He applied relatively high force, pushing the connector plug into the slot, leading to bending of the cable.After impedance check resulted in all contacts showing high impedance, the plug was removed, cleaned and inserted again.The setscrew was loosened further.The plug was cleaned with distilled water and dried with a clean compress.The plug was visually inspected and seemed to be slightly bent and very flexible between contact 1 and 2.The plug was reinserted but stopped short of the usual position.When it was again removed, part of the plug remained in the slot of the ins.

Event Description

Additional information was received from the manufacturer representative (rep) that revision surgery is planned for wednesday, march 27.The cause of the extensions breaking during the initial surgery was not determined.The ins and both extensions were replaced.All impedances are in a normal range now and the issue seems to be resolved.

Manufacturer Narrative

Medtronic submits this report to comply with fda regulations 21 cfr parts 4 and 803.Medtronic has made reasonable efforts to provide 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.Any required fields that are unpopulated are blank because the information is currently unknown or unavailable.Medtronic will submit a supplemental report if additional relevant information becomes known.

Event Description

Additional information was received with the pre-op session report showing left stn monopolar contacts 1, 2, and 3 were >5k.Bipolar contacts 0/2, 0/3, 1/2, 1/3, and 2/3 were >10k.Right monopolar contact 11 was >5k and all bipolar contact 11 pairs were >10k.

Manufacturer Narrative

D10.Product id 3708660, serial# (b)(6), product type extension product id 3708660, serial# (b)(6), product type extension h3: analysis results were not available at the time of this report.A follow-up report will be sent when analysis is completed.Medtronic submits this report to comply with fda regulations 21 cfr parts 4 and 803.Medtronic has made reasonable efforts to provide 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.Any required fields that are unpopulated are blank because the information is currently unknown or unavailable.Medtronic will submit a supplemental report if additional relevant information becomes known.

Manufacturer Narrative

Continuation of d10: product id (b)(4) lot# serial# (b)(6) implanted: explanted: product type extension product id (b)(6) lot# serial# (b)(6) implanted: explanted: product type extension product id (b)(4) lot# serial# (b)(6) implanted: explanted: product type extension product id (b)(4) lot# serial# (b)(6) implanted: explanted: product type extension medtronic submits this report to comply with fda regulations 21 cfr parts 4 and 803.Medtronic has made reasonable efforts to provide 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.Any required fields that are unpopulated are blank because the information is currently unknown or unavailable.Medtronic will submit a supplemental report if additional relevant information becomes known.

Event Description

It was reported that the extension cable broke during a replacement normal battery replacement procedure.Stimulation to the affected hemisphere was discontinued.Because the patient wasn't ready to undergo full anesthesia, patient had to be left without stimulation by the affected electrode, exposing her to a risk of rebound symptoms.The plug could not be inserted into the implantable neurostimulator (ins) slot to reach its usual end position.It stopped approximately 2mm short of the end position.After removing and visually inspecting the plug, it seemed slightly bent, but showed a seemingly normal flexibility.The setscrew fastener loosened as far as possible.After reinserting, the same problem still existed.Impedances of contact 11 were above normal. the insulation of the extension was aged visibly, showing a yellowish color.First, the surgeon experienced problems inserting the extension plug into the percept's connector slot.He applied relatively high force, pushing the connector plug into the slot, leading to bending of the cab le.After impedance check resulted in all contacts showing high impedance, the plug was removed, cleaned and inserted again.The setscrew was loosened further.The plug was cleaned with distilled water and dried with a clean compress.The plug was visually inspected and seemed to be slightly bent and very flexible between contact 1 and 2.The plug was reinserted but stopped short of the usual position.When it was again removed, part of the plug remained in the slot of the ins.Additional information was received from the manufacturer representative (rep) that revision surgery is planned for wednesday, march 27.The cause of the extensions breaking during the initial surgery was not determined.Additional information was received with the pre-op session report showing left stn monopolar contacts 1, 2, and 3 were >5k.Bipolar contacts 0/2, 0/3, 1/2, 1/3, and 2/3 were >10k.Right monopolar contact 11 was >5k and all bipolar contact 11 pairs were >10k.The ins and both extensions were replaced.All impedances are in a normal range now and the issue seems to be resolved.

Manufacturer Narrative

Continuation of d10: product id 37085-60 lot# serial# (b)(6) implanted: explanted: product type extension product id 37085-60 lot# serial# (b)(6) implanted: explanted: product type extension product id 3708660 lot# serial# (b)(6) implanted: explanted: product type extension product id 3708660 lot# serial# (b)(6) implanted: explanted: product type extension h3: ins - analysis identified that the extension (or extension parts) could not be removed from inside the implantable neurostimulator (ins) connector port.Pli 40 - (b)(6) - analysis identified environmentally assisted degradation of the insulation at the proximal end of the extension.Analysis identified that the conductor was broken at the proximal end of the extension.Pli 50 - (b)(6) - analysis identified environmentally assisted degradation of the insulation at the proximal end of the extension.Medtronic submits this report to comply with fda regulations 21 cfr parts 4 and 803.Medtronic has made reasonable efforts to provide 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.Any required fields that are unpopulated are blank because the information is currently unknown or unavailable.Medtronic will submit a supplemental report if additional relevant information becomes known.

• Brand Name: PERCEPT
• 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: glen belmer ; 7000 central avenue ne rcw215; minneapolis, MN 55432 ; 6122713209
• MDR Report Key: 18960333
• MDR Text Key: 338373749
• Report Number: 3004209178-2024-07651
• Device Sequence Number: 1
• Product Code: MHY
• Combination Product (y/n): N
• Reporter Country Code: SZ
• PMA/PMN Number: P960009
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Company Representative
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup,Followup,Followup,Followup
• Report Date: 06/12/2024

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 Model Number: B35200
• Device Catalogue Number: B35200
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Initial Date Manufacturer Received: 03/13/2024
• Initial Date FDA Received: 03/22/2024
• Supplement Dates Manufacturer Received: 03/22/2024; 03/28/2024; 03/30/2024; 05/30/2024
• Supplement Dates FDA Received: 04/03/2024; 04/09/2024; 04/29/2024; 06/12/2024
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 12/04/2023
• 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
• Treatment: "SEE H11...."
• Patient Outcome(s): Required Intervention
• Patient Sex: Female