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

Model Number 37612

Device Problems Failure to Interrogate (1332); Improper or Incorrect Procedure or Method (2017); Low Battery (2584); Device Displays Incorrect Message (2591); Communication or Transmission Problem (2896)

Patient Problems Muscle Spasm(s) (1966); Therapeutic Response, Decreased (2271); Discomfort (2330); Neck Pain (2433); Neck Stiffness (2434)

Event Type  malfunction  

Event Description

It was reported that the patient had been unable to communicate with his device using his ¿controller¿.Earlier that day, the patient described a ¿shocking feeling¿ and ¿presumed¿, it was a static shock from being in contact with someone while they were removing their short.Other symptoms the patient experienced included pain and spasms in the left side of the neck.When the patient attempted to communicate with his device a few hours later, he saw the ¿poor communication¿ icon and then the patient¿s symptoms returned.The return of symptoms was described as stiffness in the neck.Communication with the clinician programmer was also not possible.An x-ray was performed and found to be ¿unremarkable¿.It was suspected that the device had overdischarged for the first time.A physician mode recharge (pmr) was attempted but was unsuccessful.The patient was reportedly given diazepam to ease the discomfort in the neck.Another pmr was going to be attempted over the weekend.If successful, impedance values were going to be measured prior to any intervention.Approximately two weeks later, it was reported that the overdischarge was confirmed.Per recharge efficacy information retrieved from the recharger, a successful recharge was performed the day prior to the event.Troubleshooting/intervention was going to be confirmed when the surgeon reviewed the patient.The reporter was awaiting news from the hospital.

Manufacturer Narrative

(b)(4).

Manufacturer Narrative

Analysis results were not available as of the date of this report.A follow-up report will be submitted when analysis is complete.

Event Description

Additional information reported that impedance testing and replacement was scheduled for six days after follow-up.Additional information reported that during surgery the top of the implantable neurostimulator (ins) was exposed and the lead adapter was removed from channel 1.It was stated the lead adapter was then connected to an external neurostimulator (ens) with care being taken "to ensure the leads in the ins pocket weren't disturbed in case the short circuit was intermittent." it was further stated an impedance test was performed at that time and that "the impedances were all in the normal range with active contacts being 882 and 980 ohms." it was noted that because these values "weren't low enough for a short circuit," the patient's ins was replaced at that time.Upon reprogramming of the patient's ins, impedance measurements were taken and "all readings were within range." it was also reported that when the patient's original ins was completely flat, they remained unable to recharge the device.

Manufacturer Narrative

Device evaluation: analysis of the implantable neurostimulator (ins) found ¿the ins was received with no telemetry and no output.A physician mode recharge (pmr) resulted in "invalid serial number" on the physician programmer and a 601 error code on the recharger.After several hours, the ins went back to no telemetry.Subsequent physician mode recharges produced the same result.The cause of this error was a copper trace anomaly that was observed on the exposed traces on the substrate of the hybrid's stacked chip scale package (scsp).The copper trace anomaly was between the traces for address (xa8) and voltage supply trace (vdig_2v).Mud cracking residue was also observed on several traces on the substrate of the stacked chip scale package (scsp).¿.

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 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: 3785121
• MDR Text Key: 16224824
• Report Number: 3004209178-2014-08389
• Device Sequence Number: 1
• Product Code: MRU
• Combination Product (y/n): N
• Reporter Country Code: UK
• PMA/PMN Number: H020007
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,Company Representative,company representati
• Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup,Followup
• Report Date: 04/10/2014

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: 12/28/2013
• Device Model Number: 37612
• Device Catalogue Number: 37612
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/16/2014
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 08/20/2014
• Initial Date FDA Received: 05/01/2014
• Supplement Dates Manufacturer Received: Not provided; Not provided; 08/20/2014
• Supplement Dates FDA Received: 05/29/2014; 08/21/2014; 09/14/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 02/01/2013
• 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