MAUDE Adverse Event Report: MEDTRONIC MED REL MEDTRONIC PUERTO RICO ACTIVA; STIMULATOR, ELECTRICAL, IMPLANTED, FOR PARKINSONIAN TREMOR

Model Number 37601

Device Problems Low Battery (2584); Device Displays Incorrect Message (2591); Device Operates Differently Than Expected (2913)

Patient Problems Therapeutic Effects, Unexpected (2099); No Known Impact Or Consequence To Patient (2692)

Event Date 01/05/2015

Event Type  Injury  

Event Description

It was reported the patient had their battery replaced due to expected longevity, no therapy or product issues were noted.Following the replacement they checked the stimulator and were ¿getting the same results.¿ the battery was okay but it said estimated replacement indicator (eri) and 2.5 volts.The batteries in the programmer were taken out to reset the programmer but they still saw the eri.The programmer was returned because it would not interrogate.Analysis revealed the antenna jack was resoldered as a preventative measure.Later it was noted that during the replacement the physician removed the stimulator after doing a slight pocket revision and the depleted stimulator was accidentally put back in the pocket instead of the new stimulator.The event was related to the device or therapy and implant procedure.The patient underwent an additional surgery to replace the stimulator.Following replacement the event was considered resolved without sequelae.

Event Description

Additional information received reported that the pocket revision was done to extract the old implantable neurostimulator (ins) and implant the correct new one.There was a note that the operating room technician passed off the old ins as new.It was noted that the new ins was discarded during the procedure.

Manufacturer Narrative

Concomitant medical products: product id: 37085-60, serial# (b)(4), product type: extension.Product id: 37085-60, serial# (b)(4), product type: extension.Product id: 37642, serial# (b)(4), product type: programmer, patient.Product id: 3389s-40, lot# v484000, product type: lead.(b)(4).

Event Description

Additional information received reported that there was not a 50 percent or greater symptom reduction.The implantable neurostimulator (ins) was the component involved in the reported event.Actions taken to resolve the issue included surgery to replace unit.The cause of the event was determined and was related to the device.The patient recovered without permanent impairment.The patient underwent a replacement of her ins several days prior to report.When the patient got home the unit was not functioning properly.The healthcare professional (hcp) office was suspicious that either the old unit had been placed back into the incision or the new unit was not functioning correctly.The patient was taken to the operating room and placed under anesthesia in the spine position.The left upper anterior chest was prepped with sterile solution and draped.The old incision was reopened and some previous clot washed out and removed.Next the ins came into view.The stitches holding it in place were cut and the old unit was temporarily explanted.The wires were then loosened and taken out and placed into the new unit.The old unit was then passed off the table.The pocket containing the implant was then irrigated copiously and some vancomycin powder placed into the pocket and the generator was placed back in the pocket and tacked to the pectoral fascia using a 2-0 silk stitch.The incision was closed in a couple of layers of interrupted 3-0 vicryl sutures, followed by running 5-0 fast absorbing stitch for the skin and ointment.While still asleep, the unit was re-interrogated.The battery functioning was assessed and found to be normal.The serial numbers were checked with the implant that was handed on and found to be correct and the impedances were all correct.The new implant was performing as expected and should work for her and her previous settings were transferred into the new system.The estimated blood loss was less than 50 ml.All sponge counts and needle counts were correct.

Manufacturer Narrative

(b)(4).

• Brand Name: ACTIVA
• Type of Device: STIMULATOR, ELECTRICAL, IMPLANTED, FOR PARKINSONIAN TREMOR
• Manufacturer (Section D): MEDTRONIC MED REL MEDTRONIC PUERTO RICO; ceiba norte industrial park, r; 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: 4452643
• MDR Text Key: 5389319
• Report Number: 3004209178-2015-01216
• Device Sequence Number: 1
• Product Code: MHY
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: P960009
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Study,Consumer,Health Professional,consumer,health prof
• Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup,Followup
• Report Date: 09/08/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/26/2015
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 04/28/2012
• Device Model Number: 37601
• Device Catalogue Number: 37601
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 08/16/2016
• Date Device Manufactured: 10/28/2010
• 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: 00069 YR