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

Model Number 37612

Device Problems Delayed Charge Time (2586); Charging Problem (2892); Communication or Transmission Problem (2896)

Patient Problem Therapeutic Response, Decreased (2271)

Event Date 10/20/2014

Event Type  malfunction  

Event Description

Additional information received reported the implantable neurostimulator (ins) was the device that had depleted which was due to the patient not recharging properly.The manufacturing representative had not heard from the patient since switching out the charger that they thought may have been faulty.

Event Description

It was reported there was a faulty cable on the recharger.Achieving coupling with the telemetry head and the rc seemed dependent on manipulating the cord where it connected to the recharging unit.It would drop from 8 bars to 4 by the manipulation of the grey cord at the proximal end.The issue caused difficulty and lengthy recharging sessions.The rc apparently depleted and the patient¿s symptoms returned but they were able to recharge and the symptoms resolved.A replacement was required as a result of the event and the issue was resolved.The recharging coupling appeared to be much easier.The patient status at the time of report was alive with no injury.Additional information received one day later reported that they had difficulty keeping the coupling bars.The problem started over the weekend and the patient was left with a different recharger for them to try the day prior to report.The patient still had problems one day later.On (b)(6) 2014 the manufacturer representative had not heard anything further for the patient so they ¿assumed they had gotten the hang of things.¿.

Manufacturer Narrative

Concomitant medical products: product id: 37651, product type recharger.Product id: 37651 serial# (b)(4), product type recharger.Product id: 3387s-40, lot# va05gwe , implanted: (b)(6)2013-product type: lead.Product id: 3387s-40, lot# va05gwe, implanted: (b)(6)2013, product type: lead.Product id: 37642, serial# (b)(6), product type: programmer, patient.Product id: 3708660, lot# serial# (b)(4) implanted: (b)(6) 2013, product type: extension.Product id: 3708660, lot# serial# (b)(4) implanted: (b)(6) 2013, product type: extension.

Manufacturer Narrative

(b)(4).

Manufacturer Narrative

Concomitant products: product id: 37651, product type: recharger.Product id: 37651, serial# (b)(4), product type: recharger.Product id: 3387s-40, lot# va05gwe, implanted: (b)(6) 2013, product type: lead.Product id: 3387s-40, lot# va05gwe, implanted: (b)(6) 2013, product type: lead.Product id: 37642, serial# (b)(4), product type: programmer, patient.Product id: 3708660, serial# (b)(4), implanted: (b)(6) 2013, product type: extension.Product id: 3708660, serial# (b)(4), implanted: (b)(6) 2013, product type: extension.

Event Description

Additional information indicated that upon return and analysis of the recharger analysis found the complaint was unverified.

• 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: 4243440
• MDR Text Key: 5394330
• Report Number: 3004209178-2014-21309
• 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: Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup,Followup
• Report Date: 10/20/2014

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: 07/14/2015
• Device Model Number: 37612
• Device Catalogue Number: 37612
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 01/15/2015
• Initial Date FDA Received: 11/11/2014
• Supplement Dates Manufacturer Received: Not provided; Not provided; Not provided
• Supplement Dates FDA Received: 12/19/2014; 01/16/2015; 01/22/2015
• Date Device Manufactured: 08/18/2014
• 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 Age: 00022 YR