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

Model Number 37601

Device Problems Low impedance (2285); Low Battery (2584); Battery Problem (2885)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Type  Injury  

Event Description

It was reported that there were low impedances.Impedance testing and reprogramming were done.The short circuit and noting that the device was at elective replacement indicator (eri) had been discovered at the patient¿s last appointment with their provider.On the date of this report prior to surgery the device was interrogated to confirm a short circuit but all impedances were within normal limits.The device was at eri while implantable neurostimulator (ins) voltage was reading 2.92.The device was replaced on the date of this report.The patient was alive with no injury.Prior to the short circuit being discovered the patient had fallen in her home but had denied hitting any part of the deep brain stimulator system.The patient¿s generator was in the abdomen.No outcome was provided.Further follow-up is being conducted to obtain this information.If additional information is received a supplemental report will be submitted.

Event Description

Additional information received reported the short was between 8 and 9, it was in the 30¿s.The settings for the patient when they had come in and the short was found were 9+8-, 130 pulse width, 5.8v, 90hz.The patient was reprogrammed to 10+8-, 3.5v, 130 pulse width, 90 hz.Therapy impedance after reprogramming had measured 1381 ohms, 2.92ma.The voltage was decreased because it had been discovered at the same time that the device was at eri and they were uncertain how quickly she would be approved for a replacement.This was a dystonia patient.

Event Description

Additional information received reported that at the time of explant due to normal elective replacement indicator (eri), the impedances had returned to normal around 1,000 ohms.When the short circuit was discovered, the impedances between electrode eight and nine was in the 30s ohms.The healthcare professional (hcp) was able to successfully program around the short with good therapy results.The manufacturing representative did not know when the patient fell.The implantable neurostimulator (ins) battery life seemed within reasonably limits given the patient¿s settings.There were no lead fractures noted.The patient¿s scalp was not opened at the time of the ins replacement.The ins was programmed in continuous mode.All impedances were measured to be within normal limits after the ins was replaced and the patient continued to receive effective therapy with the new ins.

Manufacturer Narrative

Concomitant medical products: product id 3387s-40, lot# va0huz5, implanted: (b)(6) 2014, product type: lead; product id 3387s-40, lot# va0huz5, implanted: (b)(6) 2014, product type: lead; product id 3708695, serial# (b)(4), implanted: (b)(6) 2014, product type: extension; product id 3708695, serial# (b)(4), implanted: (b)(6) 2014, product type: extension.(b)(4).(b)(6).Analysis results were not available at the time of this report.A follow-up report will be sent when analysis is completed.

Manufacturer Narrative

Analysis of the implantable neurostimulator found no significant anomalies, the battery was at normal end of life and telemetry and output were ok.

Manufacturer Narrative

Result and eval - conclusion have been updated.

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 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: 4454444
• MDR Text Key: 5425906
• Report Number: 3004209178-2015-01227
• Device Sequence Number: 1
• Product Code: MRU
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: H020007
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Company Representative,company representative
• Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup,Followup
• Report Date: 01/08/2015

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: 09/14/2015
• Device Model Number: 37601
• Device Catalogue Number: 37601
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/16/2015
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 03/11/2015
• Initial Date FDA Received: 01/27/2015
• Supplement Dates Manufacturer Received: Not provided; Not provided; 03/11/2015
• Supplement Dates FDA Received: 02/27/2015; 03/16/2015; 09/18/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 03/14/2014
• 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: 00063 YR